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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Prime Screen® Multi-Panel Urine Test (10 Panel Card: AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC), 25T/Box
WONDFO USA CO., LTD.
DWDOA-3104-25BX-A
In Commercial Distribution

  • 10816862024026 ()
  • 00816862024029 ()
  • 00816862024036 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 9 Panel Test Cup w/Adulterants, AMP/BAR/BZO/COC/mAMP/MOR/MTD/PCP/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-2397-0-A
In Commercial Distribution

  • 00816036025494 ()
  • 00816036025487 ()
SCP-2397-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 10 Panel Test Cup W/AD, AMP/BAR/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/ + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STAII-03107-0-A
In Commercial Distribution

  • 00816036025463 ()
  • 00816036025456 ()
STAII-03107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 6 Panel CLIA Waived Test Cup, with Adulterants 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC +pH, OX, CR.
MICRO DISTRIBUTING, L.C
STATII-4267-0-A
In Commercial Distribution

  • 00816036025401 ()
  • 00816036025418 ()
STATII-4267-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 10 Panel Test Cup W/AD, AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-41107-0-A
In Commercial Distribution

  • 00816036025111 ()
  • 00816036025272 ()
STATⅡ-41107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 10 Panel Test Cup W/AD, AMP/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-12107-0-A
In Commercial Distribution

  • 00816036025081 ()
  • 00816036025241 ()
STATⅡ-12107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
FASTEST 12 Panel CLIA WAIVED Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
FST-71127
In Commercial Distribution

  • 00816036021687 ()
  • 00816036021694 ()
FST-71127

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - 14 Panel Clicker Cup Test: AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/PPX300/TCA1000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-1145
In Commercial Distribution

  • 00895330002592 ()


  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, reagent
  • Nortriptyline IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methadone IVD, reagent
CRL STAT 12 Panel Cup - KCUR920092 AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MTD300/OPI300/OXY100/PCP25/THC50 (SG/CR/OX)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920092
In Commercial Distribution

  • 00817815021171 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 10 panel Cup - KCUR920083 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/THC50 (pH/SG/OX/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920083
In Commercial Distribution

  • 00817815021119 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 10 panel Cup - KCUR920126 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/THC50(OX/SG/pH/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920126
In Commercial Distribution

  • 00817815020655 ()
  • 00817815020662 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The T2Bacteria Cartridge components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Bacteria panel.
T2 BIOSYSTEMS, INC.
90-08071
In Commercial Distribution

  • M70890080710 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Identify® Diagnostics Drug Test Cards 10 Panel Drug Test Card THC/COC/MOP/OXY/MDMA/AMP/BAR/BZO/MET/MTD
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-DIP-AZ10
In Commercial Distribution

  • 20850721007680 ()
  • 10850721007683 ()
  • 00850721007686 ()
ID-CP10-DIP-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home TM Drug Screening Test Cards 9 Panel Drug Test Card AMP/BUP/BZO/COC/mAMP/MOP/MTD/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
UCP9-DIP-B-394
In Commercial Distribution

  • 20850721007529 ()
  • 10850721007522 ()
  • 00850721007525 ()
UCP9-DIP-B-394

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 10 panel Drug Test Card THC/COC/MOP/OXY/MDMA/AMP/BAR/BZO/MET/MTD
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-DIP-AZ25
In Commercial Distribution

  • 20850721007499 ()
  • 10850721007492 ()
  • 00850721007495 ()
ID-CP10-DIP-AZ25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 10 panel Drug Test Card THC/COC/MOP/OXY/MDMA/AMP/BAR/BZO/MET/MTD
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-DIP-AZ5
In Commercial Distribution

  • 20850721007482 ()
  • 10850721007485 ()
  • 00850721007488 ()
ID-CP10-DIP-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen™ Urine Test Drug Screen Card 12 Panel (AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/TCA/THC)
Instant Technologies, Inc.
IS12BUP-DX2
In Commercial Distribution

  • 00817405021321 ()
  • 10817405021328 ()
IS12BUP-DX2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen™ Urine Test Drug Screen Card 12 Panel (AMP/BAR/BZO/COC/MDMA/MET/MOP/MTD/OXY/PCP/TCA/THC)
Instant Technologies, Inc.
IS12-DX2
In Commercial Distribution

  • 00817405021314 ()
  • 10817405021311 ()
IS12-DX2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup BAR/BUP/BZO/COC/MET/MTD/OPI/OXY/TCA/THC with Adulteration strip(S.G.,CRE, pH)
UCP BIOSCIENCES, INC.
U-DUD-7104
In Commercial Distribution

  • 20817038021419 ()
  • 10817038021412 ()
  • 00817038021415 ()
U-DUD-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Fastep 12 Panel Urine Drug Test Cup (AMP, BAR, BUP, BZO, COC, MET, MDMA, MOP,MTD, OXY, PCP, THC) – 4 pack
Azure Biotech, Inc.
AZC-6125
In Commercial Distribution

  • 00810022630396 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Opaque, 1 1/2" (38Mm)
CONVATEC, PURCHASING DEPARTMENT
416751
In Commercial Distribution

  • 10768455112217 ()
  • 00768455112210 ()
  • 00768455188604 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Transparent, 1 1/2" (38Mm)
CONVATEC, PURCHASING DEPARTMENT
416750
In Commercial Distribution

  • 10768455112200 ()
  • 00768455112203 ()
  • 00768455188598 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Opaque, 1 3/8" (35Mm)
CONVATEC, PURCHASING DEPARTMENT
416749
In Commercial Distribution

  • 10768455112194 ()
  • 00768455112197 ()
  • 00768455188581 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Transparent, 1 3/8" (35Mm)
CONVATEC, PURCHASING DEPARTMENT
416748
In Commercial Distribution

  • 10768455112187 ()
  • 00768455112180 ()
  • 00768455188574 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Opaque, 1 1/4" (32Mm)
CONVATEC, PURCHASING DEPARTMENT
416747
In Commercial Distribution

  • 10768455112170 ()
  • 00768455112173 ()
  • 00768455188567 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Transparent, 1 1/4" (32Mm)
CONVATEC, PURCHASING DEPARTMENT
416746
In Commercial Distribution

  • 10768455112163 ()
  • 00768455112166 ()
  • 00768455188550 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Opaque, 1 1/8" (28Mm)
CONVATEC, PURCHASING DEPARTMENT
416745
In Commercial Distribution

  • 10768455112156 ()
  • 00768455112159 ()
  • 00768455188543 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Transparent, 1 1/8" (28Mm)
CONVATEC, PURCHASING DEPARTMENT
416744
In Commercial Distribution

  • 10768455112149 ()
  • 00768455112142 ()
  • 00768455188536 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Opaque, 1 9/16" (40Mm)
CONVATEC, PURCHASING DEPARTMENT
416737
In Commercial Distribution

  • 10768455112071 ()
  • 00768455112074 ()
  • 00768455188468 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Tranparent, 1 9/16" (40Mm)
CONVATEC, PURCHASING DEPARTMENT
416736
In Commercial Distribution

  • 10768455112064 ()
  • 00768455112067 ()
  • 00768455188451 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Opaque, 1 3/8" (35Mm)
CONVATEC, PURCHASING DEPARTMENT
416733
In Commercial Distribution

  • 10768455112033 ()
  • 00768455112036 ()
  • 00768455188437 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Tranparent, 1 3/8" (35Mm)
CONVATEC, PURCHASING DEPARTMENT
416732
In Commercial Distribution

  • 10768455112026 ()
  • 00768455112029 ()
  • 00768455188420 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Opaque, 1 3/16" (30Mm)
CONVATEC, PURCHASING DEPARTMENT
416729
In Commercial Distribution

  • 10768455111999 ()
  • 00768455111992 ()
  • 00768455188413 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Tranparent, 1 3/16" (30Mm)
CONVATEC, PURCHASING DEPARTMENT
416728
In Commercial Distribution

  • 10768455111982 ()
  • 00768455111985 ()
  • 00768455188406 ()


  • One-piece intestinal ostomy bag, open-ended
ActiveLife One-Piece Cut-to-Fit Closed-End Pouch with Skin Barrier and Filter, with 1 Sided Comfort Panel, Opaque, 3/4 in. (19 mm)
CONVATEC, PURCHASING DEPARTMENT
413141
Not in Commercial Distribution

  • 10768455106025 ()
  • 00768455106028 ()
  • 80768455106024 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Cut-To-Fit Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Opaque, 3/4 in (19 mm)
CONVATEC, PURCHASING DEPARTMENT
175768
Not in Commercial Distribution

  • 10768455102430 ()
  • 00768455102433 ()
  • 80768455102439 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Cut-To-Fit Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Transparent, 3/4 in (19 mm)
CONVATEC, PURCHASING DEPARTMENT
175761
Not in Commercial Distribution

  • 10768455102379 ()
  • 00768455102372 ()
  • 80768455102378 ()


  • One-piece intestinal ostomy bag, closed-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Opaque, 2" (50Mm.)
CONVATEC, PURCHASING DEPARTMENT
125343
In Commercial Distribution

  • 10768455102041 ()
  • 00768455102044 ()
  • 00768455180578 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Opaque, 1" (25Mm.)
CONVATEC, PURCHASING DEPARTMENT
125339
In Commercial Distribution

  • 10768455102003 ()
  • 00768455102006 ()
  • 00768455180530 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 10" Opaque, 2" (50Mm.)
CONVATEC, PURCHASING DEPARTMENT
125336
In Commercial Distribution

  • 10768455101976 ()
  • 00768455101979 ()
  • 00768455180509 ()


  • One-piece intestinal ostomy bag, open-ended
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