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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u-Card Drug Test Screen AMP Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-AMP-114L
In Commercial Distribution

  • 20817038021877 ()
  • 10817038021870 ()
  • 00817038021873 ()
U-AMP-114L

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
u-Card Drug Test Screen MOP Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-MOP-114L
In Commercial Distribution

  • 20817038021846 ()
  • 10817038021849 ()
  • 00817038021842 ()
U-MOP-114L

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
u-Card Drug Test Screen OXY Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-OXY-114L
In Commercial Distribution

  • 20817038021839 ()
  • 10817038021832 ()
  • 00817038021835 ()
U-OXY-114L

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
u-Card Drug Test Screen Opiates Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-OPI-114L
In Commercial Distribution

  • 20817038021822 ()
  • 10817038021825 ()
  • 00817038021828 ()
U-OPI-114L

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
5 Panel Drug Test Cup AMP/COC/OPI/PCP/THC
UCP BIOSCIENCES, INC.
U-CUP-154
In Commercial Distribution

  • 20817038021273 ()
  • 10817038021276 ()
  • 00817038021279 ()
U-CUP-154

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

  • 20817038021150 ()
  • 10817038021153 ()
  • 00817038021156 ()
U-DOA-264L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Test Cup AMP/COC/MET/OPI/THC
UCP BIOSCIENCES, INC.
U-CUP-254
In Commercial Distribution

  • 20817038021112 ()
  • 10817038021115 ()
  • 00817038021118 ()
U-CUP-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
90cm single pivot 7 panel under table shield low profile
AADCO MEDICAL, INC.
S-315
In Commercial Distribution

  • 00840348508772 ()
S-315

  • Radiation shielding table drape
MRI-SAFE UNDER-TBL MTD RAD SHIELD 70CMX90CM WIDE W/TOP PANEL
AADCO MEDICAL, INC.
S-314NF
In Commercial Distribution

  • 00840348508758 ()
S-314NF

  • Radiation shielding table drape
BINDER, ABDOMINAL, 12" LG/XL (46"-62"), 4 PANEL, WHITE
Asp Global, LLC
1058LXL-ASP
In Commercial Distribution

  • 00840216117594 ()


  • Abdominal binder, reusable
BINDER, ABDOMINAL, 12" S/M (30"-45"), 4 PANEL, WHITE
Asp Global, LLC
1058SM-ASP
In Commercial Distribution

  • 00840216117563 ()


  • Abdominal binder, reusable
BINDER, ABDOMINAL, 9" LG/XL (46"-62"), 3 PANEL, WHITE
Asp Global, LLC
1057LXL-ASP
In Commercial Distribution

  • 00840216117556 ()


  • Abdominal binder, reusable
BINDER, ABDOMINAL, 9" S/M (30"-45"), 3 PANEL, WHITE
Asp Global, LLC
1057SM-ASP
In Commercial Distribution

  • 00840216117549 ()


  • Abdominal binder, reusable
Sony Medical Grade Flat Panel Monitor, HD, without stand, 24"
BR Surgical, LLC
BR900-4424
In Commercial Distribution

  • 00840183514006 ()
BR900-4424

  • Image display unit, colour
accutest MultiDrug Screen- 5 panel (AMP/COC/MET/THC/OPI)
JANT PHARMACAL CORPORATION
DS01AC425
In Commercial Distribution

  • 10763924001429 ()
  • 00763924001422 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel Home Drug Test Kit THC COC OPI MET
CONFIRM BIOSCIENCES, INC.
RO-DRC004
In Commercial Distribution

  • 00895330002370 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Panel 08 COC/ THC/AMP/MAMP/OPI2/MDMA/OXY/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020169
In Commercial Distribution

  • 10858904006300 ()
  • 00858904006303 ()
DOA-184-471

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-COC-MET500-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI,GL
Express Diagnostic Int'l, Inc.
60740-6
In Commercial Distribution

  • B29860740610 ()
60740-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Cup Drug Test, AMP-COC-MET500-OPI300-PCP-THC-pH,SG,OX-CR,NI,GL
Express Diagnostic Int'l, Inc.
60613-6
In Commercial Distribution

  • B29860613610 ()
60613-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Dip Drug Test, AMP-BARB-BZO-COC-MDMA-MET500-MTD-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI,GL
Express Diagnostic Int'l, Inc.
31106-6
In Commercial Distribution

  • B2983110660 ()
31106-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BARB-BZO-COC-MET500-MTD-OPI300-OXY-THC-pH,SG,OX-CR,NI,GL
Express Diagnostic Int'l, Inc.
30908-6
In Commercial Distribution

  • B2983090860 ()
30908-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel OralTox - AMP/COC/MET/OPI/OXY/PCP/THC
PREMIER BIOTECH, INC
OT80701
Not in Commercial Distribution

  • B313OT807011 ()
  • B313OT807010 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 PANEL CLIA WAIVED SQUARE CUP AMP1000, COC300, MET1000, OPI2000
Instant Technologies, Inc.
ABTDOAW14701A
In Commercial Distribution

  • 30817405023319 ()
  • 00817405023318 ()
  • 10817405023315 ()
ABTDOAW14701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Dip Cards 12 DRUG PANEL WITH ADULTERANTS
MCKESSON MEDICAL-SURGICAL INC.
16-DTDC12P
In Commercial Distribution

  • 20612479255337 ()
  • 10612479255323 ()
  • 40612479255348 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Dip Cards 10 DRUG PANEL WITH ADULTERANTS
MCKESSON MEDICAL-SURGICAL INC.
16-DTDC10P
In Commercial Distribution

  • 20612479255306 ()
  • 10612479255293 ()
  • 40612479255317 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Inspiration Ventilator System, model 7i Flagship with 17" Display Panel
Event Medical, Ltd.
Inspiration Ventilator System
In Commercial Distribution

  • B079EVM11000103US0 ()
F7300000-7i-F-US

  • General-purpose intensive-care ventilator
QC Sets and Panels: Helix Elite™ SARS-CoV-2 Verification Panel
MICROBIOLOGICS INC.
ABT-001
In Commercial Distribution

  • 80845357043708 ()
ABT-001

  • SARS-CoV-2 nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Vaginal Control Panel
MICROBIOLOGICS INC.
8209
In Commercial Distribution

  • 70845357041325 ()
8209

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Vaginal Verification Panel
MICROBIOLOGICS INC.
8208
In Commercial Distribution

  • 70845357041318 ()
8208

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
QC Sets and Panels: KWIK-STIK™ Gram Positive Identification Panel
MICROBIOLOGICS INC.
5248P
In Commercial Distribution

  • 70845357039940 ()
5248P

  • Multiple bacteria species culture isolate identification control IVD, kit
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