Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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MDC-855 5 Panel Cup CLIA Waived (COC300/MET1000/AMP1000/MOP300 /OXY100)
Medical Disposables Corp
MDC-855
In Commercial Distribution

  • 00860007913129 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MDC-855 5 Panel Cup CLIA Waived (COC300/MET1000/AMP1000/MOP300 /OXY100)
Medical Disposables Corp
MDC-855
In Commercial Distribution

  • 00860007913112 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MDC-855 5 Panel Cup CLIA Waived (COC300/MET1000/AMP1000/MOP300 /OXY100)
Medical Disposables Corp
MDC-855
In Commercial Distribution

  • 00860007913105 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UScreen Oral® Saliva Drug Test Pen, 5 Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
USSORAL-5NT-EUO
In Commercial Distribution

  • 30850065976281 ()
  • 00850065976280 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cotinine IVD, kit, rapid ICT, clinical
Allow connection of the single use sensor to the Panel PC.
EVENTUM ORTHOPAEDICS LTD
CA001
In Commercial Distribution

  • 05065012584233 ()


  • Electrical-only medical device connection cable, reusable
ORT 400 (Trumpf TruSystem 7500 MR) table, Control Panel Assy 119409-000
IMRIS Imaging, Inc.
ORT 400 (Trumpf TruSystem 7500 MR) Control Panel Assy
In Commercial Distribution

  • 00857534006509 ()


  • MRI system table, powered
  • Basic diagnostic x-ray system table, powered
ePlex Blood Culture Identification Gram Negative (GN) Panel 12-test kit box
GENMARK DIAGNOSTICS, INC.
BCID-GN 12 Kit Box
In Commercial Distribution

  • 00857167005313 ()
EA002012

  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
Medical Grade HD Flat Panel Monitor, with DVI and HD, 22"
BR Surgical, LLC
BR900-4422
In Commercial Distribution

  • 00857556008505 ()
BR900-4422

  • Image display unit, colour
NexScreen Drug Dip Card 5 Panel COC150/THC50/AMP500/OPI2000/PCP25
NEXSCREEN, LLC
NCard-05-01
In Commercial Distribution

  • 00858984006286 ()
NCard-05-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Flat Panel hi-resolution LCD monitor system for displaying digital medical images.
WIDE corporation
CW60
In Commercial Distribution

  • 08809241513063 ()


  • Image display unit, colour
Flat panel hi-resolution LCD monitor system for displaying digital medical images.
WIDE corporation
CX20PUX
In Commercial Distribution

  • 08809241513056 ()


  • Image display unit, colour
Flat panel hi-resolution LCD monitor system for displaying digital medical images.
WIDE corporation
CX30PQX
In Commercial Distribution

  • 08809241513049 ()


  • Image display unit, colour
Flat panel hi-resolution LCD monitor system for displaying digital medical images.
WIDE corporation
CX50YQS
In Commercial Distribution

  • 08809241513032 ()


  • Image display unit, colour
Flat panel hi-resolution LCD monitor system for displaying digital medical images.
WIDE corporation
MX30TQS
In Commercial Distribution

  • 08809241513025 ()


  • Image display unit, colour
Flat panel hi-resolution LCD monitor system for displaying digital medical images.
WIDE corporation
MX50YQS
In Commercial Distribution

  • 08809241513018 ()


  • Image display unit, colour
Flat panel hi-resolution LCD monitor system for displaying digital medical images.
WIDE corporation
MX50TQS
In Commercial Distribution

  • 08809241513001 ()


  • Image display unit, colour
6PLUS1® Multilevel Serum Calibrator Set MassChrom® Steroid Panel 2
Chromsystems Instruments + Chemicals GmbH
72039
In Commercial Distribution

  • 04250317533425 ()

  • Total Volume: 3 Milliliter
  • 7 Vials
72039

  • Multiple steroid hormone IVD, calibrator
6PLUS1® Multilevel Serum Calibrator Set MassChrom® Steroid Panel 1
Chromsystems Instruments + Chemicals GmbH
72038
In Commercial Distribution

  • 04250317533340 ()

  • Total Volume: 3 Milliliter
  • 7 Vials
72038

  • Multiple steroid hormone IVD, calibrator
REAR MOUNT LAMINATE WORKSURFACE & WALL MOUNT PANEL SIDE DELIVERY, FOREST GREY
Ls Enterprises, Inc.
3386WM-G
In Commercial Distribution

  • D0693386WMG0 ()


  • Dental delivery system
Knob with pointer, for control panel in the Xenon Administration System
Medi/Nuclear Corporation, Inc.
XE-102-23
In Commercial Distribution

  • 00850022357374 ()


  • Xenon administration system, diagnostic x-ray/CT
Healgen (DrugConfirm) - 5 Panel Dip Card - AMP1000/COC300/mAMP1000/MOP2000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-254
In Commercial Distribution

  • 00895330002707 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
6 Panel Dip Card - CLIA - COC/AMP/mAMP/THC/OPI/BZO
CONFIRM BIOSCIENCES, INC.
CB-HE-264
In Commercial Distribution

  • 00895330002653 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
VITEK REVEAL BC GN02-AST is an antibiotic panel (20 panels/box)
BIOMERIEUX , INC.
VITEK® REVEAL™ BC GN02-AST
In Commercial Distribution

  • 03573026638894 ()
  • 03573026638887 ()


  • Antibacterial susceptibility testing disc IVD
Medical Grade HD Flat Panel Monitor, with DVI and HDSDI, 26"
BR Surgical, LLC
BR900-4426
In Commercial Distribution

  • 00840183513610 ()
BR900-4426

  • Image display unit, colour
Identify®Diagnostics Drug Test CardsTHC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP
In Commercial Distribution

  • 20850721007642 ()
  • 10850721007645 ()
  • 00850721007648 ()
ID-THC-DIP

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
5 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY
MEDICAL DISTRIBUTION GROUP INC
U-CUP-1254-RCN
In Commercial Distribution

  • 20850721007109 ()
  • 10850721007102 ()
  • 00850721007105 ()
U-CUP-1254-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ACIST CVi® Contrast Delivery System Control Panel, p/n 701557-002
ACIST MEDICAL SYSTEMS, INC.
016227
In Commercial Distribution

  • 10841716101899 ()


  • Angiography contrast medium injection system, line-powered, mobile
PANEL 09 COC150/AMP300/BZO/MAMP500/MDMA/OPI300/OXY/PCP/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020181
In Commercial Distribution

  • 10858904006386 ()
  • 00858904006389 ()
DOA-194-291

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 09 COC/THC/OPI300/AMP/MAMP/PCP/BZO/OXY/BUP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020180
In Commercial Distribution

  • 10858904006379 ()
  • 00858904006372 ()
DOA-194-281

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OEM 81-13 Drug Test 3 Panel Dip Card AMP/COC/THC
UCP BIOSCIENCES, INC.
U-DOA-134
In Commercial Distribution

  • 20817038022126 ()
  • 10817038022129 ()
  • 00817038022122 ()
U-DOA-134

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
5 Panel Drug Screening Test Cup BZO/THC/OPI300/OXY/BUP
UCP BIOSCIENCES, INC.
U-CUP-1454-RCN
In Commercial Distribution

  • 20817038020610 ()
  • 10817038020613 ()
  • 00817038020616 ()
U-CUP-1454-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Screening Test Cup BZO/COC/MET/OPI300/OXY
UCP BIOSCIENCES, INC.
U-CUP-1354-RCN
In Commercial Distribution

  • 20817038020566 ()
  • 10817038020569 ()
  • 00817038020562 ()
U-CUP-1354-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup mAMP-COC-THC/MOP-MDMA/MTD/BAR-BZO/AMP/OXY
UCP BIOSCIENCES, INC.
U-CUP-3104
In Commercial Distribution

  • 20817038020559 ()
  • 10817038020552 ()
  • 00817038020555 ()
U-CUP-3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Drug Test Card COC/AMP/mAMP/THC/OPI/BZO
UCP BIOSCIENCES, INC.
U-DOA-264
In Commercial Distribution

  • 20817038020481 ()
  • 10817038020484 ()
  • 00817038020487 ()
U-DOA-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Beds LTC Accessories Product Description Staff Control Panel f/P703 ,1ea
Drive Devilbiss Healthcare
P703SC04
In Commercial Distribution

  • 00822383979564 ()


  • Electrical assistive bed
  • Basic electric home bed
CRL STAT 5 panel Dip - KCUR920106 AMP1000/COC300/OPI2000/PCP25/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920106
In Commercial Distribution

  • 00817815021294 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Multi-Drug Screen Panel, OPI2000/MET1000/THC50/COC300/PCP25 Cassette Tests
CLINICAL REFERENCE LABORATORY, INC.
X04-PC12
In Commercial Distribution

  • 00817815021003 ()
X04-PC12

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 5 panel Cup- KCUR920074 COC300/MET1000/OPI2000/PCP25/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920074
In Commercial Distribution

  • 00817815020938 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QC Sets and Panels: Helix Elite™ Rapid SARS-CoV-2 Control Panel
MICROBIOLOGICS INC.
8268
In Commercial Distribution

  • 70845357044364 ()
8268

  • SARS-CoV-2 nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Multiplex Vaginal Verification Panel
MICROBIOLOGICS INC.
8245
In Commercial Distribution

  • 70845357043695 ()
8245

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
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