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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UCP Home Drug Screening Test Cards BUP Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-BUP-114
In Commercial Distribution

  • 20817038021464 ()
  • 10817038021467 ()
  • 00817038021460 ()
U-BUP-114

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cards THC Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-THC-114
In Commercial Distribution

  • 20817038021457 ()
  • 10817038021450 ()
  • 00817038021453 ()
U-THC-114

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
7 Panel Drug Test Cup BUP/BZO/COC/MTD/MOP/OXY/THC
UCP BIOSCIENCES, INC.
U-CUP-274
In Commercial Distribution

  • 20817038021310 ()
  • 10817038021313 ()
  • 00817038021316 ()
U-CUP-274

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Drug Test Cup AMP/BZO/COC/MET/OPI/OXY/THC
UCP BIOSCIENCES, INC.
U-CUP-174
In Commercial Distribution

  • 20817038021297 ()
  • 10817038021290 ()
  • 00817038021293 ()
U-CUP-174

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UNDER-TBL MTD RAD SHIELD 70CM H X 90CM W WITH TOP PANEL
AADCO MEDICAL, INC.
S-314
In Commercial Distribution

  • 00840348529197 ()
S-314

  • Radiation shielding table drape
PANEL 11 COC/THC/OPI/AMP/MAMP/BARBZO/MTD/OXY/PCP/BUP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020185
In Commercial Distribution

  • 10858904006423 ()
  • 00858904006426 ()
DOA-1114-111

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 10 COC/THC/OPI300/AMP/MAMP/BZO/BAR/OXY/MTD/BUP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020182
In Commercial Distribution

  • 10858904006393 ()
  • 00858904006396 ()
DOA-1104-531

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 10 COC/AMP/M-AMP/THC/MTD/OPI/PCP/BAR/BZO/TCA
REDWOOD TOXICOLOGY LABORATORY, INC.
011020025
In Commercial Distribution

  • 10858904006294 ()
  • 00858904006297 ()
DOA-2104-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 10 COC/M-AMP/THC/MTD/MDMA/OPI/OXY/PCP/BAR/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020138
In Commercial Distribution

  • 10858904006478 ()
  • 00858904006471 ()
DOA-1104-401

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OEM 81-13 Drug Test 4 Panel Dip Card AMP/COC/THC/MET
UCP BIOSCIENCES, INC.
U-DOA-244
In Commercial Distribution

  • 20817038022164 ()
  • 10817038022167 ()
  • 00817038022160 ()
U-DOA-244

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cards OXY Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-OXY-114
In Commercial Distribution

  • 20817038021709 ()
  • 10817038021702 ()
  • 00817038021705 ()
U-OXY-114

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
90cm single pivot 7 panel under table shield low profile RIGHT HAND
AADCO MEDICAL, INC.
S-315R
In Commercial Distribution

  • 00840348508789 ()
S-315R

  • Radiation shielding table drape
UNDER-TBL MTD RAD SHIELD 70CM H X 90CM W WITH TOP PANEL
AADCO MEDICAL, INC.
S-314A
In Commercial Distribution

  • 00840348508734 ()
S-314A

  • Radiation shielding table drape
QC Sets and Panels: Helix Elite™ Pneumonia (33 Targets) Control Panel
MICROBIOLOGICS INC.
8244
Not in Commercial Distribution

  • 70845357043664 ()
8244

  • Multiple-type respiratory pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Respiratory Control Panel (22 Targets)
MICROBIOLOGICS INC.
8247
In Commercial Distribution

  • 70845357043619 ()
8247

  • Multiple-type respiratory pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Respiratory (21 Targets) Control Panel
MICROBIOLOGICS INC.
8217
Not in Commercial Distribution

  • 70845357042506 ()
8217

  • Multiple-type respiratory pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Norovirus Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8205
In Commercial Distribution

  • 70845357041400 ()
8205

  • Norovirus nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Enteric Parasite Verification Panel (Synthetic)
MICROBIOLOGICS INC.
8182
Not in Commercial Distribution

  • 70845357041356 ()
8182

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Human Papillomavirus (HPV) Verification Panel
MICROBIOLOGICS INC.
8216
Not in Commercial Distribution

  • 70845357041134 ()
8216

  • Human papillomavirus (HPV) nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Human Papillomavirus (HPV) Control Panel
MICROBIOLOGICS INC.
8214
Not in Commercial Distribution

  • 70845357041127 ()
8214

  • Human papillomavirus (HPV) nucleic acid IVD, control
QC Sets and Panels: KWIK-STIK™ Enteric Bacterial Verification Panel (Live Culture)
MICROBIOLOGICS INC.
8179
In Commercial Distribution

  • 70845357036635 ()
8179

  • Multiple bacteria species culture isolate identification control IVD, kit
QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel.
Opgen, Inc.
AC043
Not in Commercial Distribution

  • 20812125010079 ()
AC043

  • Specimen processing instrument IVD
SUR-FIT Natura® Drainable Pouch, 14" Tran W/1-Sided Comfort Panel, 4"
CONVATEC, PURCHASING DEPARTMENT
401515
In Commercial Distribution

  • 10768455103376 ()
  • 00768455103379 ()
  • 00768455182541 ()


  • Multiple-piece urostomy bag, open-ended
6 Panel Drug Screening Test Cup BZO/COC/MET/OPI300/OXY/AMP
UCP BIOSCIENCES, INC.
U-CUP-1264-RCN
In Commercial Distribution

  • 20817038020627 ()
  • 10817038020620 ()
  • 00817038020623 ()
U-CUP-1264-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Drug Screening Test Cup BZO/COC/OPI300/OXY/AMP/BUP
UCP BIOSCIENCES, INC.
U-CUP-1164-RCN
In Commercial Distribution

  • 20817038020597 ()
  • 10817038020590 ()
  • 00817038020593 ()
U-CUP-1164-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Drug Screening Test Cup BZO/COC/THC/MET/OPI300/AMP
UCP BIOSCIENCES, INC.
U-CUP-1064-RCN
In Commercial Distribution

  • 20817038020573 ()
  • 10817038020576 ()
  • 00817038020579 ()
U-CUP-1064-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The HarmonyAIR M5 Dual Package with 2 Single Flat Panel Monitor, without Control, with 2 Flat Panel Monitors and Tandems, is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995172657 ()
LM03NT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The M5 High Density Dual Package, Single Flat Panel Monitor Mount, Auxiliary Arm Single Flat Panel Monitor, No Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191580 ()
LMH03

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
BlueRapids CLIA Waived Drug Cup; 6 Panel AMP/BZO/COC/MET/OPI2000/THC
MERCEDES MEDICAL, LLC
TNR CDOA261
In Commercial Distribution

  • 20850011007031 ()
  • 10850011007034 ()
  • 00850011007037 ()
TNR CDOA261

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
TMK-IFAK Insert is a low-profile medical panel outfitted with critical lifesaving medical supplies.
Altitude Technologies Inc.
01237REF
In Commercial Distribution

  • 00850018892520 ()
01237REF

  • First aid kit, non-medicated, single-use
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