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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Healgen (DrugConfirm) - 10 Panel CLIA Cup AMP1000/BAR300/BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-3104
In Commercial Distribution

  • 00895330002769 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Oxycodone IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
10 Panel Flat-Cup w/ADU COC/THC/OPI/AMP/mAMP/BZO/MTD/OXY/MDMA/BUP+A3
CONFIRM BIOSCIENCES, INC.
CB-HE-FLATCUP-8104A3
In Commercial Distribution

  • 00895330002745 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - 10 Panel CLIA Cup AMP1000/BUP10/ BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/OXY100/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-8104
In Commercial Distribution

  • 00895330002677 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
PANEL 12 COC/THC/OPI300/AMP/MAMP/PCP/BZO/BAR/MTD/MDMA/OXY/BUP WITH SVT ???
REDWOOD TOXICOLOGY LABORATORY, INC.
011020188
In Commercial Distribution

  • 10858904006430 ()
  • 00858904006433 ()
DOA-1124-081

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Phototherapy Unit. UVB Narrowband. Single upright panel with Four 72" lamps. Mounts to wall or stand.
Medtek Lighting Corporation
40B
In Commercial Distribution

  • B343B40 ()

  • Area/Surface Area: 1311 Square inch
  • Weight: 150 Pound
40B

  • Ultraviolet phototherapy unit, professional
Phototherapy Unit. UVB Narrowband. Single upright panel with 10 lamps. Mounts to wall or to stand.
Medtek Lighting Corporation
100B
In Commercial Distribution

  • B343B100 ()

  • Area/Surface Area: 1311 Square inch
  • Weight: 180 Pound
100B

  • Ultraviolet phototherapy unit, professional
CRL STAT 5 panel Dip - KCUR920102 AMP500/COC150/MET500/OPI2000/THC50 (pH/SG/OX/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920102
In Commercial Distribution

  • 00817815021263 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 10 panel Dip - KCUR920085 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920085
In Commercial Distribution

  • 00817815021201 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 5 panel Cup - KCUR920079 COC300/MET1000/OPI2000/PCP25/THC50 (pH/SG/OX/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920079
In Commercial Distribution

  • 00817815021027 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 9 Panel Dip - KCUR920075 AMP1000/BAR300/BZO300/COC300/MET 1000/MTD300/OPI2000/PCP25/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920075
In Commercial Distribution

  • 00817815020969 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen 10 Panel CLIA Click Cup AMP1000, BAR300, BZO300, COC300, MET1000, MDMA500, MOP300, MTD300, OXY100, THC50
Instant Technologies, Inc.
ABTDOAW110701A
In Commercial Distribution

  • 30817405024118 ()
  • 00817405024117 ()
  • 10817405024114 ()
ABTDOAW110701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Privacy EUO Oral Fluid COC20, OPI40, MDMA50, OXY20, THC40, 6AM/HRN10, MET50, AMP50, PCP10
Instant Technologies, Inc.
ABTOFCUBE0903C
In Commercial Distribution

  • 30817405024033 ()
  • 00817405024032 ()
  • 10817405024039 ()
ABTOFCUBE0903C

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel E&I Oral Click Cube AMP50, BUP5, BZO10, COC20, MET50, MTD30, OPI40, OXY20, THC40
Instant Technologies, Inc.
ABTOFCUBE0902B
In Commercial Distribution

  • 30817405023913 ()
  • 00817405023912 ()
  • 10817405023919 ()
ABTOFCUBE0902B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 PANEL E&I OF CUBE AMP50/BAR20/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/PCP10/THC40
Instant Technologies, Inc.
ABTOFCUBE1001A
In Commercial Distribution

  • 30817405023579 ()
  • 00817405023578 ()
  • 10817405023575 ()
ABTOFCUBE1001A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 PANEL 510(K) SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, PCP25, THC50
Instant Technologies, Inc.
ABTDOAK110701A
In Commercial Distribution

  • 30817405023470 ()
  • 00817405023479 ()
  • 10817405023476 ()
ABTDOAK110701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 PANEL CLIA WAIVED DIP CARD AMP1000, BAR300, BUP10, BZO300, COC300, MET1000, MTD300, OPI2000, OXY100, THC50
Instant Technologies, Inc.
ABTDOAW110401A
In Commercial Distribution

  • 30817405023463 ()
  • 00817405023462 ()
  • 10817405023469 ()
ABTDOAW110401A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 PANEL CLIA WAIVED SQUARE CUP AMP1000, BZO300, COC300, MOP300, OXY100, THC50 SVT (CR,OX,S.G.)
Instant Technologies, Inc.
ABTDUAW16701A
In Commercial Distribution

  • 30817405023258 ()
  • 00817405023257 ()
  • 10817405023254 ()
ABTDUAW16701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup, AMP500/BAR/BZO/COC150/MET500/MTD/OPI300/PCP/PPX/THC(Ox/pH/SG)
CHEMTRON BIOTECH INC
PCA-10X3X-ALT
In Commercial Distribution

  • 00812203030506 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QC Sets and Panels: Helix Elite™ Molecular Standards Blood Culture Identification Control Panel (43 Targets)
MICROBIOLOGICS INC.
8254
In Commercial Distribution

  • 70845357044098 ()
8254

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
7 Panel DOA Test Clear Flat Cup + Adulterant Test Strips SG/PH/OX+CR/NI/GL
Healgen Scientific Limited Liability Company
HCDOAF-274A6
In Commercial Distribution

  • 10816490024122 ()
  • 00816490024125 ()
  • 20816490024129 ()
HCDOAF-274A6

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

  • 00816036025388 ()
  • 00816036025395 ()
STATII-4267-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 5 Panel Test Cup W/AD, AMP/COC/mAMP/OPI/THC + pH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-1257-0-A
In Commercial Distribution

  • 00816036025012 ()
  • 00816036025180 ()
STATⅡ-1257-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup With Clicker + 3 Adulterant Test Strips OXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-5125A3
In Commercial Distribution

  • 20816490020824 ()
  • 10816490020827 ()
  • 00816490020820 ()
HCDOAV-5125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Round Cup With Clicker;+3 Adulterant Test Strips OXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-6124A3
In Commercial Distribution

  • 20816490020800 ()
  • 10816490020803 ()
  • 00816490020806 ()
HCDOAV-6124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup With Clicker;+3 Adulterant Test Strips OXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-6125A3
In Commercial Distribution

  • 20816490020794 ()
  • 10816490020797 ()
  • 00816490020790 ()
HCDOAV-6125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OEC MiniView C-Arm with 15cm FPD (Flat Panel Detector) Drape, Intended For Use With: OEC MiniView
TIDI PRODUCTS, LLC
31047
In Commercial Distribution

  • 10618125190826 ()
  • 00618125190812 ()
8849416

  • Medical equipment/instrument drape, single-use
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Stomahesive, One-Sided Comfort Panel 12" Transparent, (40/50Mm)
CONVATEC, PURCHASING DEPARTMENT
413520
In Commercial Distribution

  • 10768455130228 ()
  • 00768455130221 ()
  • 00768455187805 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Stomahesive, One-Sided Comfort Panel 12" Transparent, (30/40Mm)
CONVATEC, PURCHASING DEPARTMENT
413519
In Commercial Distribution

  • 10768455130211 ()
  • 00768455130214 ()
  • 00768455187799 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem Synergy®+ 12" Drainable Pouch W/Invisiclose® Outlet & Filter / Two-Sided Comfort Panel / Opaque / Large
CONVATEC, PURCHASING DEPARTMENT
416902
In Commercial Distribution

  • 10768455114884 ()
  • 00768455114887 ()
  • 00768455188789 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ 12" Drainable Pouch W/Invisiclose® Outlet & Filter / One-Sided Comfort Panel / Transparent / Large
CONVATEC, PURCHASING DEPARTMENT
416901
In Commercial Distribution

  • 10768455114877 ()
  • 00768455114870 ()
  • 00768455188772 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ 12" Drainable Pouch W/Invisiclose® Outlet & Filter / Two-Sided Comfort Panel / Opaque / Medium
CONVATEC, PURCHASING DEPARTMENT
416799
In Commercial Distribution

  • 10768455114853 ()
  • 00768455114856 ()
  • 00768455188758 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ 12" Drainable Pouch W/Invisiclose® Outlet & Filter / One-Sided Comfort Panel / Transparent / Medium
CONVATEC, PURCHASING DEPARTMENT
416798
In Commercial Distribution

  • 10768455114846 ()
  • 00768455114849 ()
  • 00768455188741 ()


  • Multiple-piece intestinal ostomy bag, open-ended
Esteem Synergy®+ 12" Drainable Pouch W/Invisiclose® Outlet & Filter / Two-Sided Comfort Panel / Opaque / Small
CONVATEC, PURCHASING DEPARTMENT
416796
In Commercial Distribution

  • 10768455114822 ()
  • 00768455114825 ()
  • 00768455188727 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ 12" Drainable Pouch W/Invisiclose® Outlet & Filter / One-Sided Comfort Panel / Transparent / Small
CONVATEC, PURCHASING DEPARTMENT
416795
In Commercial Distribution

  • 10768455114815 ()
  • 00768455114818 ()
  • 00768455188710 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem®+ One-Piece Pre-Cut Closed-End Pouch, Modified Stomahesive, Filter, One-Sided Comfort Panel, 8" Opaque, 2" (50Mm)
CONVATEC, PURCHASING DEPARTMENT
416715
In Commercial Distribution

  • 10768455111852 ()
  • 00768455111855 ()
  • 00768455188314 ()


  • One-piece intestinal ostomy bag, closed-ended
Esteem®+ One-Piece Pre-Cut Closed-End Pouch, Modified Stomahesive, Filter, One-Sided Comfort Panel, 8" Opaque, 1" (25Mm)
CONVATEC, PURCHASING DEPARTMENT
416704
In Commercial Distribution

  • 10768455111746 ()
  • 00768455111749 ()
  • 00768455188215 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura® Little Ones® Mini-Pouch, W/2 Sided Comfort Panel, Opaque 1 3/4"
CONVATEC, PURCHASING DEPARTMENT
401931
In Commercial Distribution

  • 10768455104182 ()
  • 00768455104185 ()
  • 00768455183289 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Little Ones® Mini-Pouch, W/2 Sided Comfort Panel, Opaque 1 1/4"
CONVATEC, PURCHASING DEPARTMENT
401930
In Commercial Distribution

  • 10768455104175 ()
  • 00768455104178 ()
  • 00768455183272 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® High Output Pouch Opaque W/1-Sided Comfort Panel W/Filter 2 3/4"
CONVATEC, PURCHASING DEPARTMENT
401559
In Commercial Distribution

  • 10768455103741 ()
  • 00768455103744 ()
  • 00768455182947 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® High Output Pouch Opaque W/1-Sided Comfort Panel W/Filter 2 1/4"
CONVATEC, PURCHASING DEPARTMENT
401558
In Commercial Distribution

  • 10768455103734 ()
  • 00768455103737 ()
  • 00768455182930 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® High Output Pouch Opaque W/1-Sided Comfort Panel W/Filter 1 3/4"
CONVATEC, PURCHASING DEPARTMENT
401557
In Commercial Distribution

  • 10768455103727 ()
  • 00768455103720 ()
  • 00768455182923 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura Closed-End Pouch, with Filter, Opaque with Two Sided Comfort Panel, 2 3/4 in
CONVATEC, PURCHASING DEPARTMENT
401528
Not in Commercial Distribution

  • 10768455103451 ()
  • 00768455103454 ()
  • 80768455103450 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Closed-End Pouch with Filter, Opaque with Two Sided Comfort Panel, 2 1/4 in
CONVATEC, PURCHASING DEPARTMENT
401527
Not in Commercial Distribution

  • 10768455103444 ()
  • 00768455103447 ()
  • 80768455103443 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Closed-End Pouch with Filter, Opaque with Two Sided Comfort Panel, 1 3/4 in
CONVATEC, PURCHASING DEPARTMENT
401526
Not in Commercial Distribution

  • 10768455103437 ()
  • 00768455103430 ()
  • 80768455103436 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Closed-End Pouch with Filter, Opaque with Two Sided Comfort Panel, 1 1/2 in
CONVATEC, PURCHASING DEPARTMENT
401525
Not in Commercial Distribution

  • 10768455103420 ()
  • 00768455103423 ()
  • 80768455103429 ()


  • One-piece intestinal ostomy bag, closed-ended
No Description
CANON INC.
CSX-30
In Commercial Distribution

  • 04549292075175 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.6
In Commercial Distribution

  • 00854344007610 ()


  • X-ray system computer, diagnostic, general-purpose
Nexus DRF v3.1.2
VAREX IMAGING CORPORATION
v3.1.2
In Commercial Distribution

  • 00854344007474 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.2.0
In Commercial Distribution

  • 00854344007443 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
v3.0.0
In Commercial Distribution

  • 00854344007276 ()


  • X-ray system computer, diagnostic, general-purpose
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