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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UScreen with 10 Panel Drug Screen for (THC/COC/OPI300/AMP/MET/BAR/BZO/MDMA/MTD/OXY)
Instant Technologies, Inc.
USSCup-10MMO300
Not in Commercial Distribution

USSCup-10MMO300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup W/ AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/(Cr/Ox/pH)
CHEMTRON BIOTECH INC
PCA-10NTSC-LC
In Commercial Distribution

  • 00812203030568 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, AMP/COC/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-5P
Not in Commercial Distribution

  • 00816565020236 ()
IMCA-5P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-5M
Not in Commercial Distribution

  • 00816565020229 ()
IMCA-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, BZO300/COC300/MTD300/OPI300/THC50 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-5BO3
Not in Commercial Distribution

  • 00816565020212 ()
IMCA-5BO3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP/PPX/THC), 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-31107-0
In Commercial Distribution

  • 00816036027160 ()
  • 00816036026668 ()
SCP-31107-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup w/Adulterants, BZO/COC/mAMP/MOR/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-6157-0-A
In Commercial Distribution

  • 00816036027092 ()
  • 00816036026590 ()
SCP-6157-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-21107-0
In Commercial Distribution

  • 00816036026552 ()
  • 00816036027054 ()
SCP-21107-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup w/Adulterants, COC/mAMP/OPI/PCP/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-3257-0-A
In Commercial Distribution

  • 00816036026538 ()
  • 00816036027030 ()
SCP-3257-0-A

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

  • 00816036026514 ()
  • 00816036027016 ()
SCP-1257-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 6 Panel Test Cup W/AD, BZO/COC/mAMP/MOR/OXY/THC + pH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-6167-0-A
In Commercial Distribution

  • 00816036025050 ()
  • 00816036025227 ()
STATⅡ-6167-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 6 Panel Test Cup W/AD, AMP/BZO/COC/mAMP/MOR/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-2167-3-0-A
In Commercial Distribution

  • 00816036025043 ()
  • 00816036025210 ()
STATⅡ-2167-3-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Dip Card - CLIA - COC,THC,OPI,AMP,PCP,TCA,BZO,BAR,MTD,MDMA,OXY,BUP
CONFIRM BIOSCIENCES, INC.
CB-HE-3124 
In Commercial Distribution

  • 00895330002868 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Dip Card - CLIA - COC,THC,OPI,AMP,PCP,TCA,BZO,BAR,MTD,MDMA,OXY,BUP
CONFIRM BIOSCIENCES, INC.
CB-HE-3124
In Commercial Distribution

  • 00895330002790 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - 10 Panel Dip Card - CLIA - AMP1000/BAR300/BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-3104
In Commercial Distribution

  • 00895330002776 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate 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
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
Identify® Diagnostics Drug Test Cards 6 Panel Drug Test Card THC/COC/MOP/OXY/MET/BZO
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-DIP-AZ25
In Commercial Distribution

  • 20850721007703 ()
  • 10850721007706 ()
  • 00850721007709 ()
ID-CP6-DIP-AZ25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 6 Panel Drug Test Card THC/COC/MOP/OXY/MET/BZO
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-DIP-AZ10
In Commercial Distribution

  • 20850721007628 ()
  • 10850721007621 ()
  • 00850721007624 ()
ID-CP6-DIP-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 6 panel Drug Test Card THC/COC/MOP/OXY/MET/BZO
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-DIP-AZ5
In Commercial Distribution

  • 20850721007543 ()
  • 10850721007546 ()
  • 00850721007549 ()
ID-CP6-DIP-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cups 5 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY
UCP BIOSCIENCES, INC.
U-CUP-1254-RCN
In Commercial Distribution

  • 20817038021587 ()
  • 10817038021580 ()
  • 00817038021583 ()
U-CUP-1254-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MTD/OPI/OXY/PCP/PPX/THC
UCP BIOSCIENCES, INC.
U-CUP-4124
In Commercial Distribution

  • 20817038021303 ()
  • 10817038021306 ()
  • 00817038021309 ()
U-CUP-4124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC
UCP BIOSCIENCES, INC.
U-CUP-6124
In Commercial Distribution

  • 20817038021174 ()
  • 10817038021177 ()
  • 00817038021170 ()
U-CUP-6124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Cup AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/TCA/THC
UCP BIOSCIENCES, INC.
U-CUP-3124
In Commercial Distribution

  • 20817038021136 ()
  • 10817038021139 ()
  • 00817038021132 ()
U-CUP-3124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 4 panels per pouch, 100 packages per box.
KEY SURGICAL, INC.
Sterile Labels
In Commercial Distribution

  • 50849771050761 ()
  • 10849771050763 ()
  • 00849771050766 ()
  • 00849771037811 ()
SL401

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
Sterile Labels
In Commercial Distribution

  • 50849771050754 ()
  • 10849771050756 ()
  • 00849771050759 ()
  • 00849771033257 ()
SL211

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
Sterile Labels
In Commercial Distribution

  • 50849771050747 ()
  • 10849771050749 ()
  • 00849771050742 ()
  • 00849771031109 ()
SL209

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
Sterile Labels
In Commercial Distribution

  • 50849771050730 ()
  • 10849771050732 ()
  • 00849771050735 ()
  • 00849771032731 ()
SL207

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
SL202
In Commercial Distribution

  • 50849771050716 ()
  • 10849771050718 ()
  • 00849771050711 ()
  • 00849771033479 ()
SL202

  • Procedural medication labelling set
RH UNDER TBL RAD SHEILD 70CM H X 90CM W WITH SEC TOP PANEL FOR RIGHT SIDE
AADCO MEDICAL, INC.
S-314AR
In Commercial Distribution

  • 00840348508741 ()
S-314AR

  • Radiation shielding table drape
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
Sterile Labels
In Commercial Distribution

  • 20849771052870 ()
  • 10849771052873 ()
  • 00849771052876 ()
  • 00849771032144 ()
SL210

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL208
In Commercial Distribution

  • 20849771052863 ()
  • 10849771052866 ()
  • 00849771052869 ()
  • 00849771025696 ()
SL208

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 pouches per box
KEY SURGICAL, INC.
Sterile Labels
In Commercial Distribution

  • 20849771052856 ()
  • 10849771052859 ()
  • 00849771052852 ()
  • 00849771033493 ()
SL204

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
SL201
In Commercial Distribution

  • 20849771052849 ()
  • 10849771052842 ()
  • 00849771052845 ()
  • 00849771033462 ()
SL201

  • Procedural medication labelling set
mLife Verify 9 Panel Oral Fluid Drug Test AMP BAR BZO COC MDMA MET MTD OPI OXY
Mlife Diagnostics, LLC
MV002.09.0004EI
In Commercial Distribution

  • G474MV002090004EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QC Sets and Panels: Helix Elite™ Molecular Standards Candida vaginitis/Trichomonas vaginalis (CV/TV) Control Panel
MICROBIOLOGICS INC.
8250
In Commercial Distribution

  • 70845357043749 ()
8250

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8229
In Commercial Distribution

  • 70845357042728 ()
8229

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
25-pack 10 panel drug test urine cup (THC/COC/MOP/AMP/MAMP/PCP/ BAR/BZO/MTD/OXY)
IDUN SOLUTIONS LLC
12511105000034
In Commercial Distribution

  • 90857275007813 ()


  • Oxycodone IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose®, Stomahesive, One-Sided Comfort Panel 12" Transparent, (20/30Mm)
CONVATEC, PURCHASING DEPARTMENT
413518
In Commercial Distribution

  • 10768455130204 ()
  • 00768455130207 ()
  • 00768455187782 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, One-Sided Comfort Panel 12" Transparent, (40/50Mm)
CONVATEC, PURCHASING DEPARTMENT
413517
In Commercial Distribution

  • 10768455130198 ()
  • 00768455130191 ()
  • 00768455187775 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, One-Sided Comfort Panel 12" Transparent, (30/40Mm)
CONVATEC, PURCHASING DEPARTMENT
413516
In Commercial Distribution

  • 10768455130181 ()
  • 00768455130184 ()
  • 00768455187768 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, One-Sided Comfort Panel 12" Transparent, (20/30Mm)
CONVATEC, PURCHASING DEPARTMENT
413515
In Commercial Distribution

  • 10768455130174 ()
  • 00768455130177 ()
  • 00768455187751 ()


  • One-piece intestinal ostomy bag, open-ended
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