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CSMS #18-000516
   
  Title: FDA New and End-dated CDRH Product Codes
  Date: 9/4/2018 5:15:48 PM
  To: Automated Broker Interface, ACE Outreach Events, ACE Portal Accounts, Air Manifest, New ACE Programming, Ocean Manifest, Partner Government Agencies, Rail Manifest, Truck Manifest
 
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The Food and Drug Administration has created new product codes, which will be available in 60 
days on November 5, 2018. The Food and Drug Administration is also end-dating product codes, effective in 60 days November 5, 2018. The new and end-dated codes are described below.

End-Dated Code/Description 
74D--WM/Apparatus, Suction, Patient Care
New Code/Description
73D--WM / Apparatus, Suction, Patient Care

End-Dated Code/Description
84G--ZE / Stimulator, Diaphragmatic/Phrenic Nerve, Implanted 
New Code/Description
73G--ZE / Stimulator, Diaphragmatic/Phrenic Nerve, Implanted

End-Dated Code/Description
74P--GJ / Oximeter, wellness 
New Code/Description
73P--GJ / Oximeter, wellness

End-Dated Code/Description
82J--MG / Radioimmunoassay (Two-Site Solid Phase), Ferritin 
New Code/Description
75J--MG / Radioimmunoassay (Two-Site Solid Phase), Ferritin

End-Dated Code/Description
91P--HV / Continuous glucose monitor retrospective data analysis software 
New Code/Description
75P--HV / Continuous glucose monitor retrospective data analysis software

End-Dated Code/Description
77O--HP / Expiratory resistance valve, intranasal, for obstructive sleep apnea 
New Code/Description
76O--HP / Expiratory resistance valve, intranasal, for obstructive sleep apnea

End-Dated Code/Description
84G--ZD / Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation 
New Code/Description
78G--ZD / Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation

End-Dated Code/Description
85H--IR / Perineometer
New Code/Description
78H--IR / Perineometer

End-Dated Code/Description
74M--NW / Analyzer, Body Composition
New Code/Description
78M--NW / Analyzer, Body Composition

End-Dated Code/Description
85O--TN / Mesh, surgical, gynecologic, for stress urinary incontinence, female 
New Code/Description
78O--TN / Mesh, surgical, gynecologic, for stress urinary incontinence, female

End-Dated Code/Description
80O--ZW / Ingestible event marker 
New Code/Description
78O--ZW / Ingestible event marker

End-Dated Code/Description
85P--AG / Mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, female, multi-incisi 
New Code/Description
78P--AG / Mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, female, multi-incisi

End-Dated Code/Description
85P--AH / Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, single-incision 
New Code/Description
78P--AH / Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, single-incision

End-Dated Code/Description
74P--UH / Analyzer, body composition, exempt 
New Code/Description
78P--UH / Analyzer, body composition, exempt

End-Dated Code/Description
85P--WJ / Instrumentation, surgical mesh, urogynecologic, stress urinary incontinence 
New Code/Description
78P--WJ / Instrumentation, surgical mesh, urogynecologic, stress urinary incontinence

End-Dated Code/Description
78E--XM / Truss, Umbilical 
New Code/Description
79E--XM / Truss, Umbilical

End-Dated Code/Description
78E--YN / Tray, Irrigation, Sterile 
New Code/Description
79E--YN / Tray, Irrigation, Sterile

End-Dated Code/Description
78F--BQ / Trocar, Gastro-Urology 
New Code/Description
79F--BQ / Trocar, Gastro-Urology

End-Dated Code/Description
78F--DP / Apparatus, Pneumoperitoneum, Automatic 
New Code/Description
79F--DP / Apparatus, Pneumoperitoneum, Automatic

End-Dated Code/Description
78F--SH / Tray, surgical, needle 
New Code/Description
79F--SH / Tray, surgical, needle

End-Dated Code/Description
78G--CG / Peritoneoscope 
New Code/Description
79G--CG / Peritoneoscope

End-Dated Code/Description
78G--CH / Mediastinoscope 
New Code/Description
79G--CH / Mediastinoscope

End-Dated Code/Description
78G--CI / Laryngoscope 
New Code/Description
79G--CI / Laryngoscope

End-Dated Code/Description
74M--VR / Device, Anastomotic, Microvascular 
New Code/Description
79M--VR / Device, Anastomotic, Microvascular

End-Dated Code/Description
89N--ZF / Massager, cosmetic, static electricity-emitting 
New Code/Description
79N--ZF / Massager, cosmetic, static electricity-emitting

End-Dated Code/Description
84N--ZY / Light, lymphadema reduction, low energy 
New Code/Description
79N--ZY / Light, lymphadema reduction, low energy

End-Dated Code/Description
84O--NA / Stereotaxic instrument 
New Code/Description
79O--NA / Stereotaxic instrument

End-Dated Code/Description
80P--BZ / Surgical sponge visual scale 
New Code/Description
79P--BZ / Surgical sponge visual scale

End-Dated Code/Description
78P--HU / Intra-abdominal pressure monitoring device 
New Code/Description
79P--HU / Intra-abdominal pressure monitoring device

End-Dated Code/Description
73C--AH / Filter, Bacterial, Breathing-Circuit 
New Code/Description
80C--AH / Filter, Bacterial, Breathing-Circuit

End-Dated Code/Description
74D--QF / Actuator, Syringe, Injector Type 
New Code/Description
80D--QF / Actuator, Syringe, Injector Type

End-Dated Code/Description
74D--QI / Pump, Withdrawal/Infusion 
New Code/Description
80D--QI / Pump, Withdrawal/Infusion

End-Dated Code/Description
79E--YX / Drape, Pure Latex Sheet, With Self-Retaining Finger Cot 
New Code/Description80E--YX / Drape, Pure Latex Sheet, With Self-Retaining Finger Cot

End-Dated Code/Description
79E--YY / Drape, Urological, Disposable 
New Code/Description
80E--YY / Drape, Urological, Disposable

End-Dated Code/Description
79F--IJ / System, Dialysate Delivery, Recirculating, Single Pass 
New Code/Description
80F--IJ / System, Dialysate Delivery, Recirculating, Single Pass

End-Dated Code/Description
79F--RT / Unit, Isolation, Surgical 
New Code/Description
80F--RT / Unit, Isolation, Surgical

End-Dated Code/Description
79F--XO / Suit, Surgical 
New Code/Description
80F--XO / Suit, Surgical

End-Dated Code/Description
79F--XP / Cover, Shoe, Operating-Room 
New Code/Description
80F--XP / Cover, Shoe, Operating-Room

End-Dated Code/Description
79F--XX / Mask, Surgical 
New Code/Description
80F--XX / Mask, Surgical

End-Dated Code/Description
79F--XY / Hood, Surgical 
New Code/Description
80F--XY / Hood, Surgical

End-Dated Code/Description
79F--XZ / Helmet, Surgical 
New Code/Description
80F--XZ / Helmet, Surgical

End-Dated Code/Description
79F--YA / Gown, Surgical 
New Code/Description
80F--YA / Gown, Surgical

End-Dated Code/Description
79F--YB / Gown, Patient 
New Code/Description
80F--YB / Gown, Patient

End-Dated Code/Description
79F--YC / Gown, Isolation, Surgical 
New Code/Description
80F--YC / Gown, Isolation, Surgical

End-Dated Code/Description
79F--YD / Apparatus, Exhaust, Surgical 
New Code/Description
80F--YD / Apparatus, Exhaust, Surgical

End-Dated Code/Description
79F--YH / Splint, Extremity, Noninflatable, External 
New Code/Description
80F--YH / Splint, Extremity, Noninflatable, External

End-Dated Code/Description
79H--MT / Drape, Patient, Ophthalmic 
New Code/Description
80H--MT / Drape, Patient, Ophthalmic

End-Dated Code/Description
79H--MW / Drape, Microscope, Ophthalmic 
New Code/Description
80H--MW / Drape, Microscope, Ophthalmic

End-Dated Code/Description
89I--QG / Adaptor, Holder, Syringe 
New Code/Description
80--QG / Adaptor, Holder, Syringe

End-Dated Code/Description
79K--GO / Surgeon's Gloves 
New Code/Description
80K--GO / Surgeon's Gloves

End-Dated Code/Description
79K--GQ / Cream, Gloving, Surgeon's 
New Code/Description
80K--GQ / Cream, Gloving, Surgeon's

End-Dated Code/Description
79K--GT / Drape, Adhesive, Aerosol 
New Code/Description
80K--GT / Drape, Adhesive, Aerosol

End-Dated Code/Description
79K--KX / Drape, Surgical 
New Code/Description
80K--KX / Drape, Surgical

End-Dated Code/Description
79K--KY / Material, Polytetrafluoroethylene Vitreous Carbon for Maxillofacial Reconstruction 
New Code/Description
80K--KY / Material, Polytetrafluoroethylene Vitreous Carbon for Maxillofacial Reconstruction

End-Dated Code/Description
79L--YU / Accessory, Surgical Apparel 
New Code/Description
80L--YU / Accessory, Surgical Apparel

End-Dated Code/Description
79M--AC / Decontamination kit 
New Code/Description
80M--AC / Decontamination kit

End-Dated Code/Description
79N--DC / Calculator, Drug Dose 
New Code/Description
80N--DC / Calculator, Drug Dose

End-Dated Code/Description
89N--XB / Dispenser, solid medication 
New Code/Description
80N--XB / Dispenser, solid medication

End-Dated Code/Description
74O--FM / Phlebotomy blood collection kit 
New Code/Description
80O--FM / Phlebotomy blood collection kit

End-Dated Code/Description
89O--JL / insulin vial protector/holder 
New Code/Description
80O--JL / insulin vial protector/holder

End-Dated Code/Description
79O--PA / Powder-free synthetic/non-latex surgeon's gloves 
New Code/Description
80O--PA / Powder-free synthetic/non-latex surgeon's gloves

End-Dated Code/Description
79O--VR / Kit, first aid, talking 
New Code/Description
80O--VR / Kit, first aid, talking

End-Dated Code/Description
82D--BT / Factor Xiii A, S, Antigen, Antiserum, Control 
New Code/Description
81D--BT / Factor Xiii A, S, Antigen, Antiserum, Control

End-Dated Code/Description
82D--DE / Carbonic Anhydrase C, Antigen, Antiserum, Control 
New Code/Description
81D--DE / Carbonic Anhydrase C, Antigen, Antiserum, Control

End-Dated Code/Description
82D--DF / Prothrombin, Antigen, Antiserum, Control 
New Code/Description
81D--DF / Prothrombin, Antigen, Antiserum, Control

End-Dated Code/Description
82D--DH / Carbonic Anhydrase B, Antigen, Antiserum, Control 
New Code/Description
81D--DH / Carbonic Anhydrase B, Antigen, Antiserum, Control

End-Dated Code/Description
82D--DX / Plasminogen, Antigen, Antiserum, Control 
New Code/Description
81D--DX / Plasminogen, Antigen, Antiserum, Control

End-Dated Code/Description
82D--GB / Seminal Fluid, Antigen, Antiserum, Control 
New Code/Description
81D--GB / Seminal Fluid, Antigen, Antiserum, Control

End-Dated Code/Description
82D--GQ / Whole Blood Plasma, Antigen, Antiserum, Control 
New Code/Description
81D--GQ / Whole Blood Plasma, Antigen, Antiserum, Control

End-Dated Code/Description
82D--GR / Whole Human Serum, Antigen, Antiserum, Control 
New Code/Description
81D--GR / Whole Human Serum, Antigen, Antiserum, Control

End-Dated Code/Description
88G--JH / Stain, Reticulocyte 
New Code/Description
81G--JH / Stain, Reticulocyte

End-Dated Code/Description
88G--JJ / Stains, Heinz Body 
New Code/Description
81G--JJ / Stains, Heinz Body

End-Dated Code/Description
88G--JL / Romanowsky Stains 
New Code/Description
81G--JL / Romanowsky Stains

End-Dated Code/Description
88I--AZ / Heparin 
New Code/Description
81I--AZ / Heparin

End-Dated Code/Description
88I--FO / Solution, Newcomer's 
New Code/Description
81I--FO / Solution, Newcomer's

End-Dated Code/Description
88I--FS / Solution, Helly 
New Code/Description
81I--FS / Solution, Helly

End-Dated Code/Description
88I--GK / Solution, Clarke's 
New Code/Description
81I--GK / Solution, Clarke's

End-Dated Code/Description
88I--JZ / Oil, Clearing 
New Code/Description
81I--JZ / Oil, Clearing

End-Dated Code/Description
82K--TK / Reagent, Immunoassay, Carbonic Anhydrase B and C 
New Code/Description
81K--TK / Reagent, Immunoassay, Carbonic Anhydrase B and C

End-Dated Code/Description
88L--KM / Counter, Urine Particle 
New Code/Description
81L--KM / Counter, Urine Particle

End-Dated Code/Description
85M--NA / Device, Semen Analysis 
New Code/Description
81M--NA / Device, Semen Analysis

End-Dated Code/Description
82O--VQ / Chronic lymphocytic leukemia fish probe kit 
New Code/Description
81O--VQ / Chronic lymphocytic leukemia fish probe kit

End-Dated Code/Description
82P--CZ / Investigational use only - Immunology 
New Code/Description
81P--CZ / Investigational use only - Immunology

End-Dated Code/Description
73P--HY / Sparse sample PK profile and dosing software 
New Code/Description
81P--HY / Sparse sample PK profile and dosing software

End-Dated Code/Description
88I--BB / Phytohemaglutinin M 
New Code/Description
82I--BB / Phytohemaglutinin M

End-Dated Code/Description
88K--EF / Paraformaldehyde 
New Code/Description
82K--EF / Paraformaldehyde

End-Dated Code/Description
81K--EX / Sorter, Cell 
New Code/Description
82K--EX / Sorter, Cell

End-Dated Code/Description
81L--IZ / Assay, T Lymphocyte Surface Marker 
New Code/Description
82L--IZ / Assay, T Lymphocyte Surface Marker

End-Dated Code/Description
81L--JD / Assay, B Lymphocyte Marker 
New Code/Description
82L--JD / Assay, B Lymphocyte Marker

End-Dated Code/Description
81M--AN / Assay, Interleukin 
New Code/Description
82M--AN / Assay, Interleukin

End-Dated Code/Description
81P--DX / Flow cytometry calibrator 
New Code/Description
82P--DX / Flow cytometry calibrator

End-Dated Code/Description
83P--JI / Severe combined immunodeficiency disorder (SCID) Newborn Screening Test System 
New Code/Description
82P--JI / Severe combined immunodeficiency disorder (SCID) Newborn Screening Test System

End-Dated Code/Description
82O--UY / TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM 
New Code/Description
83O--UY / TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM

End-Dated Code/Description
73B--WK / Stimulator, Electro-Acupuncture 
New Code/Description
84B--WK / Stimulator, Electro-Acupuncture

End-Dated Code/Description
89I--KN / Electromyograph, Diagnostic 
New Code/Description
84I--KN / Electromyograph, Diagnostic

End-Dated Code/Description
89I--KT / Electrode, Needle, Diagnostic Electromyograph 
New Code/Description
84I--KT / Electrode, Needle, Diagnostic Electromyograph

End-Dated Code/Description
89M--LQ / Inhibitor, Peridural Fibrosis (Adhesion Barrier) 
New Code/Description
84M--LQ / Inhibitor, Peridural Fibrosis (Adhesion Barrier)

End-Dated Code/Description
87O--AN / orthosis, cranial, laser scan 
New Code/Description
84O--AN / orthosis, cranial, laser scan

End-Dated Code/Description
77O--RR / Neurological stereotaxic instrument, real-time intraoperative mri 
New Code/Description
84O--RR / Neurological stereotaxic instrument, real-time intraoperative mri

End-Dated Code/Description
89O--TX / Foot wrap for treating restless leg syndrome symptoms 
New Code/Description
84O--TX / Foot wrap for treating restless leg syndrome symptoms

End-Dated Code/Description
89O--VP / Vibratory counter-stimulation 
New Code/Description
84O--VP / Vibratory counter-stimulation

End-Dated Code/Description
89O--ZJ / Inhibitor, postoperative fibrosis (adhesion barrier) 
New Code/Description
84O--ZJ / Inhibitor, postoperative fibrosis (adhesion barrier)

End-Dated Code/Description
89P--CQ / Inhibitor, postoperative fibrosis (spine adhesion barrier) 
New Code/Description
84P--CQ / Inhibitor, postoperative fibrosis (spine adhesion barrier)

End-Dated Code/Description
89P--HL / Powered Exoskeleton 
New Code/Description
84P--HL / Powered Exoskeleton

End-Dated Code/Description
78M--CI / Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite 
New Code/Description
85M--CI / Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite

End-Dated Code/Description
90N--RZ / Ablation System, High intensity focused Ultrasound (HIFU), MR-Guided 
New Code/Description
85N--RZ / Ablation System, High intensity focused Ultrasound (HIFU), MR-Guided

End-Dated Code/Description
74O--SV / Insfufflator, endoscopic vessel harvesting 
New Code/Description
85O--SV / Insfufflator, endoscopic vessel harvesting

End-Dated Code/Description
90P--AS / RF/Microwave hyperthermia system, cancer treatment 
New Code/Description
85P--AS / RF/Microwave hyperthermia system, cancer treatment

End-Dated Code/Description
78P--SI / Perineal irrigation kit 
New Code/Description
85P--SI / Perineal irrigation kit

End-Dated Code/Description
79J--DJ / Prosthesis, Hip, Acetabular Mesh 
New Code/Description
87J--DJ / Prosthesis, Hip, Acetabular Mesh

End-Dated Code/Description
79J--DK / Prosthesis, Hip, Cement Restrictor 
New Code/Description
87J--DK / Prosthesis, Hip, Cement Restrictor

End-Dated Code/Description
89M--BP / Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) 
New Code/Description
87M--BP / Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

End-Dated Code/Description
89M--BS / Filler, Bone Void, Non-Osteoinduction 
New Code/Description
87M--BS / Filler, Bone Void, Non-Osteoinduction

End-Dated Code/Description
89M--PW / Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction 
New Code/Description
87M--PW / Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

End-Dated Code/Description
84O--JP / orthopedic computer controlled surgical system 
New Code/Description
87O--JP / orthopedic computer controlled surgical system

End-Dated Code/Description
84O--NN / intraoperative orthopedic joint assessment aid 
New Code/Description
87O--NN / intraoperative orthopedic joint assessment aid

End-Dated Code/Description
82D--AA / Igg, Peroxidase, Antigen, Antiserum, Control 
New Code/Description
88D--AA / Igg, Peroxidase, Antigen, Antiserum, Control

End-Dated Code/Description
82D--EP / Lambda, Peroxidase, Antigen, Antiserum, Control 
New Code/Description
88D--EP / Lambda, Peroxidase, Antigen, Antiserum, Control

End-Dated Code/Description
82D--EY / Igm, Peroxidase, Antigen, Antiserum, Control 
New Code/Description
88D--EY / Igm, Peroxidase, Antigen, Antiserum, Control

End-Dated Code/Description
82D--FD / Kappa, Peroxidase, Antigen, Antiserum, Control 
New Code/Description
88D--FD / Kappa, Peroxidase, Antigen, Antiserum, Control

End-Dated Code/Description
82D--GH / Igd, Peroxidase, Antigen, Antiserum, Control 
New Code/Description
88D--GH / Igd, Peroxidase, Antigen, Antiserum, Control

End-Dated Code/Description
82D--GO / Ige, Peroxidase, Antigen, Antiserum, Control 
New Code/Description
88D--GO / Ige, Peroxidase, Antigen, Antiserum, Control

End-Dated Code/Description
82D--HF / D/Km-1, Antigen, Antiserum, Control 
New Code/Description
88D--HF / D/Km-1, Antigen, Antiserum, Control

End-Dated Code/Description
81G--IA / Test, Leukocyte Peroxidase 
New Code/Description
88G--IA / Test, Leukocyte Peroxidase

End-Dated Code/Description
82L--YE / Cytokeratins 
New Code/Description
88L--YE / Cytokeratins

End-Dated Code/Description
81M--AO / DNA-Probe, Human Chromosome 
New Code/Description
88M--AO / DNA-Probe, Human Chromosome

End-Dated Code/Description
81M--TI / Kit, Cell Screening, Fetal 
New Code/Description
88M--TI / Kit, Cell Screening, Fetal

End-Dated Code/Description
82M--VD / System, Test, HER-2/NEU, Nucleic Acid or Serum 
New Code/Description
88M--VD / System, Test, HER-2/NEU, Nucleic Acid or Serum

End-Dated Code/Description
81N--PQ / Test, Factor V Leiden Mutations, Genomic DNA PCR 
New Code/Description
88N--PQ / Test, Factor V Leiden Mutations, Genomic DNA PCR

End-Dated Code/Description
81N--PR / Test, Factor II G20210A Mutations, Genomic DNA PCR 
New Code/Description
88N--PR / Test, Factor II G20210A Mutations, Genomic DNA PCR

End-Dated Code/Description
82N--SD / Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for rec 
New Code/Description
88N--SD / Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for rec

End-Dated Code/Description
82N--TH / System, Automated scanning microscope and image analysis for fluorescience in Situ Hybridization (Fi 
New Code/Description
88N--TH / System, Automated scanning microscope and image analysis for fluorescience in Situ Hybridization (Fi

End-Dated Code/Description
82N--TW / System, Blood Collection, RNA Stabilization, RNA Purification, RT-PCR Molecular Diagnostic Test 
New Code/Description
88N--TW / System, Blood Collection, RNA Stabilization, RNA Purification, RT-PCR Molecular Diagnostic Test

End-Dated Code/Description
82N--UA / System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detention 
New Code/Description
88N--UA / System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detention

End-Dated Code/Description
82N--XG / Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion 
New Code/Description
88N--XG / Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion

End-Dated Code/Description
82N--YI / Classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer 
New Code/Description
88N--YI / Classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer

End-Dated Code/Description
82O--QS / Laboratory developed test 
New Code/Description
88O--QS / Laboratory developed test

End-Dated Code/Description
82O--WE / Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement 
New Code/Description
88O--WE / Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement

End-Dated Code/Description
82O--WM / Prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers 
New Code/Description
88O--WM / Prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers

End-Dated Code/Description
82P--AN / BRAF Mutation Kit 
New Code/Description
88P--AN / BRAF Mutation Kit

End-Dated Code/Description
82P--DO / Early growth response gene 1 (egr1) fish probe kit for specimen characterization 
New Code/Description
88P--DO / Early growth response gene 1 (egr1) fish probe kit for specimen characterization

End-Dated Code/Description
82P--FG / DNA FISH probe Kit for specimen characterization, human chromosome, hematological disorders 
New Code/Description
88P--FG / DNA FISH probe Kit for specimen characterization, human chromosome, hematological disorders

End-Dated Code/Description
82P--FR / System, cystic fibrosis transmembrane conductance regulator gene, mutations & variants panel sequenc 
New Code/Description
88P--FR / System, cystic fibrosis transmembrane conductance regulator gene, mutations & variants panel sequenc

End-Dated Code/Description
82P--FS / System, cystic fibrosis transmembrane conductance regulator gene, variant gene sequence detection 
New Code/Description
88P--FS / System, cystic fibrosis transmembrane conductance regulator gene, variant gene sequence detection

End-Dated Code/Description
81P--HJ / System, mass spectrometry, multiplex genotyping, hereditary thrombophilia related mutations 
New Code/Description
88P--HJ / System, mass spectrometry, multiplex genotyping, hereditary thrombophilia related mutations

End-Dated Code/Description
84G--ZC / Stimulator, Neuromuscular, Implanted 
New Code/Description
89G--ZC / Stimulator, Neuromuscular, Implanted

End-Dated Code/Description
87H--SS / Halter, Head, Traction 
New Code/Description
89H--SS / Halter, Head, Traction

End-Dated Code/Description
76E--AG / Cephalometer 
New Code/Description
90E--AG / Cephalometer

End-Dated Code/Description
76E--AH / Cone, Radiographic, Lead-Lined 
New Code/Description
90E--AH / Cone, Radiographic, Lead-Lined

End-Dated Code/Description
76E--AP / Unit, X-Ray, Intraoral 
New Code/Description
90E--AP / Unit, X-Ray, Intraoral

End-Dated Code/Description
76E--HB / Collimator, X-Ray 
New Code/Description
90E--HB / Collimator, X-Ray

End-Dated Code/Description
76E--HD / Unit, X-Ray, Extraoral With Timer 
New Code/Description
90E--HD / Unit, X-Ray, Extraoral With Timer

End-Dated Code/Description
94R--CC / C-Arm Fluoroscopic X-Ray System, Medical Diagnostic X-Ray Equipment 
New Code/Description
90R--CC / C-Arm Fluoroscopic X-Ray System, Medical Diagnostic X-Ray Equipment

End-Dated Code/Description
75P--FT / Reagents for molecular diagnostic test systems 
New Code/Description
91P--FT / Reagents for molecular diagnostic test systems

End-Dated Code/Description
75Q--BK / Meprobamate test system 
New Code/Description
91Q--BK / Meprobamate test system

End-Dated Code/Description
94R--IK / television, non-CRT, non-medical, video display 
New Code/Description
95R--IK / television, non-CRT, non-medical, video display

The Food and Drug Administration will be end-dating duplicate codes, effective in 60 days on _____ ___, 2018. The end-dated code and correct code are listed below.

End-Dated Code/Description
79J--CT/Prosthesis, Tracheal
Correct Code/Description
73J--CT/Prosthesis, tracheal, expandable

End-Dated Code/Description
81P--QD/Blood specimen collection convenience kit (excludes HIV)
Correct Code/Description
75P--QD/Blood specimen collection convenience kit (excludes HIV)

End-Dated Code/Description
81P--OD/Temporary, internal use hemostatic
Correct Code/Description
79P--OD/Temporary, internal use hemostatic

End-Dated Code/Description
78F--EB/Accessories, Cleaning, For Endoscope
Correct Code/Description
80F--EB/Accessories, cleaning, for endoscope

End-Dated Code/Description
79L--HF/Warmer, microwave, infusion fluid
Correct Code/Description
80L--HF/Warmer, microwave, infusion fluid

End-Dated Code/Description
74L--LK/Legging, Compression, Non-inflatable
Correct Code/Description
80L--LK/Legging, compression, non-inflatable

End-Dated Code/Description
78N--VE/Washer, Cleaner, automated, endoscope
Correct Code/Description
80N--VE/Washer, cleaner, automated, endoscope

End-Dated Code/Description
78N--ZA/Accessories, germicide, cleaning, for endoscopes
Correct Code/Description
80N--ZA/Accessories, germicide, cleaning, for endoscopes

End-Dated Code/Description
79O--FP/Basic set-up tray
Correct Code/Description
80O--FP/Anesthesia breathing circuit kit (adult & pediatric)

End-Dated Code/Description
81N--ID/Assay, Proliferation, In Vitro, T Lymphocyte
Correct Code/Description
82N--ID/Assay, Interleukin

End-Dated Code/Description
92O--WD/Somatic gene mutation detection system
Correct Code/Description
82O--WD/Somatic gene mutation detection system

End-Dated Code/Description
87H--RW/Dynamometer, nonpowered
Correct Code/Description
84H--RW/Dynamometer, nonpowered

End-Dated Code/Description
87H--ST/Apparatus, traction, non-powered
Correct Code/Description
84H--ST/Apparatus, traction, non-powered

End-Dated Code/Description
87K--QW/Goniometer, nonpowered
Correct Code/Description
84K--QW/Goniometer, nonpowered

End-Dated Code/Description
87K--QX/Goniometer, Ac-Powered
Correct Code/Description
84K--QX/Goniometer, ac-powered

End-Dated Code/Description
87L--BB/Dynamometer, Ac-Powered
Correct Code/Description
84L--BB/Dynamometer, ac-powered

End-Dated Code/Description
87L--YH/Arthrometer
Correct Code/Description
84L--YH/Arthrometer

End-Dated Code/Description
89N--HH/Device, discharge, electrostatic (for pain relief)
Correct Code/Description
84N--HH/Device, Discharge, Electrostatic (for Pain Relief)

End-Dated Code/Description
87N--KI/Goniometer with Electrodes
Correct Code/Description
84N--KI/Goniometer with electrodes

End-Dated Code/Description
86O--PT/INFRARED HEMATOMA DETECTOR
Correct Code/Description
84O--PT/INFRARED HEMATOMA DETECTOR

End-Dated Code/Description
78O--AC/plethysmograph, air displacement for body composition analysis
Correct Code/Description
85O--AC/plethysmograph, air displacement for body composition analysis

End-Dated Code/Description
89H--TM/Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive
Correct Code/Description
87H--TM/Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive

End-Dated Code/Description
92P--ZM/Next generation sequencing based tumor profiling test
Correct Code/Description
88P--ZM/Next generation sequencing based tumor profiling test

End-Dated Code/Description
95R--GC/X-Ray Field Indicator Light (Laser), Positioning Medical Laser Products
Correct Code/Description
90R--GC/X-ray field indicator light (laser)

The Food and Drug administration will be end-dating CDRH product codes, effective in 60 days on November 5, 2018. The end-dated codes are listed below.

End-Dated Code/Description
73K--GA/Cylinder, Gas(Empty)

End-Dated Code/Description
74L--IS/Heparin Coating Chemicals

End-Dated Code/Description
74L--IW/Fibrillator, AC

End-Dated Code/Description
74L--OS/System, ECG Analysis

End-Dated Code/Description
74M--NN/Device, Ablation, Varicose Vein

End-Dated Code/Description
74N--PN/Defibrillator, Automatic, External, for Out-of-Hospital Use

End-Dated Code/Description
74O--VW/Active compression/decompression pump

End-Dated Code/Description
75P--QW/alpha-D-galactosidase A (GLA) newborn screening test system

End-Dated Code/Description
76E--CF/Sterilizer, Dry Heat, Endodontic

End-Dated Code/Description
77E--NL/Nasograph

End-Dated Code/Description
77E--TL/Nasal Flowmeter

End-Dated Code/Description
77J--CS/Prosthesis, Maxilla

End-Dated Code/Description
77K--HK/Polymer, Ent Natural-Collagen Material

End-Dated Code/Description
77M--GF/Collagen, Injectable For Vocal Cord Augmentation

End-Dated Code/Description
78F--TK/Pancreatoscope, Biliary

End-Dated Code/Description
78K--OG/Endoscope And/Or Accessories

End-Dated Code/Description
78K--PG/Magnet, Continent Colostomy

End-Dated Code/Description
78L--NN/Device, Anastomosis for Gastro-Urology Use

End-Dated Code/Description
78L--TH/Graft, Vascular Access

End-Dated Code/Description
78N--NF/Set, Dialysis, Single needle (co-axial flow), Reprocessed

End-Dated Code/Description
78Q--AM/Apheresis for focal glomerulosclerosis for adult and pediatric patients

End-Dated Code/Description
79E--SY/Prosthesis, Otoplasty

End-Dated Code/Description
79K--DB/Instrument, Disposal, Surgical (Sharps)

End-Dated Code/Description
80L--DQ/Device, General Medical

End-Dated Code/Description
80N--PC/Glove, Patient Examination, Powder Free

End-Dated Code/Description
83P--RD/Biothreat microbial agents multiplex nucleic acid detection system

End-Dated Code/Description
83P--RH/Positive blood culture identification and AST kit

End-Dated Code/Description
84M--QD/Electrode, Cone, Implantable

End-Dated Code/Description
85M--MN/Ductoscope, Breast

End-Dated Code/Description
85N--HR/Material, Implant, Uterine, for Adhesiogenic Effect

End-Dated Code/Description
85N--MO/Needle, Aspiration, Oocyte, Reprocessed

End-Dated Code/Description
86O--RS/Magnetotherapy device for pain relief

End-Dated Code/Description
87M--CJ/Pump, Vacuum, Electric, Suction-Type Electrode

End-Dated Code/Description
89I--PQ/Control, Hand Driving, Automobile, Mechanical

End-Dated Code/Description
89P--GA/Electroporation, transdermal delivery

End-Dated Code/Description
91N--ED/Kit, Test, Malaria

End-Dated Code/Description
95R--FH/UV Curing, Material Processing Laser Products

End-Dated Code/Description
95R--GR/Air Purifier, Ultraviolet Commercial/Consumer

End-Dated Code/Description
95R--ZN/General Industrial Use  Material Processing Laser Products

End-Dated Code/Description
95R--ZP/Home/Office Machine Incorporating, Utility/Peripheral Laser

End-Dated Code/Description
95R--ZS/Positioning Medical Laser Product


The Food and Drug administration has created new CDRH product codes, effective immediately. The product codes are listed below.

New Code/Description
73Q—AV/ High flow/high velocity humidified oxygen delivery device

New Code/Description
73Q—BY/ Positive airway pressure system

New Code/Description
74N—PU/ Prosthesis, Mitral Valve, Percutaneously Delivered

New Code/Description
74Q—BI/ Acute coronary syndrome event detector

New Code/Description
83P—RA/ Variola virus nucleic acid-based detection assay

New Code/Description
91P—RF/ Docetaxel / Paclitaxel assay

Please send any questions or concerns to the email address for the Product Code Builder Feedback PCBFeedback@fda.hhs.gov. For questions or concerns regarding ACE, contact ACE_Support@fda.hhs.gov.
   
  Attachment(s): CDRH_end_date_and_new_codes_CSMS.xls CDRH_end_date_and_new_CSMS_draft.docx