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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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
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
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
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
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
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
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
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
NANOSPHERE, INC.
20-006-001
Not in Commercial Distribution

  • 00857573006027 ()


  • Multiple coagulation factor IVD, kit, clotting
No Description
Microgenics Corporation
10027480
In Commercial Distribution

  • 00884883007505 ()


  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
External quality controls to monitor the performance of in vitro laboratory nucleic acid detection and quantification of BCR-ABL1 fusion gene using molecular test systems.
Mmqci
v.00
In Commercial Distribution

  • 00852720008367 ()
C240

  • Philadelphia chromosome/BCR-ABL transcript IVD, control
Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for Xpert BCR-ABL Ultra assay on the Cepheid GeneXpert system.
Mmqci
v.00
In Commercial Distribution

  • 00852720008183 ()
C207

  • Philadelphia chromosome/BCR-ABL transcript IVD, control
Twelve Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MOP | MTD | OXY | PCP| TCA | THC
MERGERS MARKETING, INC.
PSC-DOA-7125
In Commercial Distribution

  • 00851000007120 ()
  • 10851000007127 ()
  • 20851000007124 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Thirteen Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | TCA | THC
MERGERS MARKETING, INC.
CSC-2135
In Commercial Distribution

  • 10850557007994 ()
  • 00850557007997 ()
  • 00850557007980 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Twelve Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | THC
MERGERS MARKETING, INC.
CSC-6125
In Commercial Distribution

  • 00850557007966 ()
  • 00850557007973 ()
  • 10850557007970 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel Clear Scan Drug Test Cup Drug Combo: THC | COC | OPI | mAMP | AMP | BZO | MTD | OXY | MDMA | BUP
MERGERS MARKETING, INC.
CSC-8104
In Commercial Distribution

  • 00850557007942 ()
  • 00850557007959 ()
  • 10850557007956 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BZO | COC | MET | MTD | OPI | OXY | PCP | THC
MERGERS MARKETING, INC.
CSC-4104
In Commercial Distribution

  • 00850557007928 ()
  • 00850557007935 ()
  • 10850557007932 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MTD | OPI | PCP | THC
MERGERS MARKETING, INC.
CSC-3104
In Commercial Distribution

  • 00850557007904 ()
  • 00850557007911 ()
  • 10850557007918 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Fourteen Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | EDDP | MDMA | MET | MOR | MTD | OXY | PCP | TCA | THC
MERGERS MARKETING, INC.
PSC-DOA-2145
In Commercial Distribution

  • 00850557007782 ()
  • 00850557007799 ()
  • 10850557007796 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Fourteen Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: COC | THC | OPI | BZO | MAMP | TCA | OXY | UP | BAR | MTD | AMP | MDMA | PCP | PPX
MERGERS MARKETING, INC.
PSC-DOA-1144
In Commercial Distribution

  • 00850557007768 ()
  • 00850557007775 ()
  • 10850557007772 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Thirteen Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR| MTD | OXY | PCP | TCA | THC
MERGERS MARKETING, INC.
PSC-DOA-2135
In Commercial Distribution

  • 00850557007720 ()
  • 00850557007737 ()
  • 10850557007734 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Twelve Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | THC
MERGERS MARKETING, INC.
PSC-DOA-6125
In Commercial Distribution

  • 00850557007683 ()
  • 00850557007690 ()
  • 10850557007697 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: THC | COC | OPI | mAMP | AMP | BZO | MTD | OXY | MDMA | BUP
MERGERS MARKETING, INC.
PSC-DOA-8104
In Commercial Distribution

  • 00850557007669 ()
  • 00850557007676 ()
  • 10850557007673 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: BAR | BUP | BZO | COC | MET | MTD | OPI | OXY | TCA | THC
MERGERS MARKETING, INC.
PSC-DOA-7104
In Commercial Distribution

  • 00850557007621 ()
  • 00850557007638 ()
  • 10850557007635 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MET | MTD | OPI | OXY | PCP | THC
MERGERS MARKETING, INC.
PSC-DOA-4104
In Commercial Distribution

  • 00850557007584 ()
  • 00850557007591 ()
  • 10850557007598 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MTD | OPI | PCP | THC
MERGERS MARKETING, INC.
PSC-DOA-3104
In Commercial Distribution

  • 00850557007508 ()
  • 00850557007515 ()
  • 10850557007512 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Drugs of Abuse (DOA-5) Panel Test is set up as a one step in-vitro test based on immunochromatography. It is designed for the qualitative determination of 5 drug substances, specifically Amphetamine, Benzodiazepine, Cocaine, Opiate, and Cannabinoid in human urine specimens.
DRG International Inc
RAP-3773
Not in Commercial Distribution

  • 00840239037732 ()
RAP-3773

  • Multiple drugs of abuse IVD, kit, thin layer chromatography
Home Drug Test Kit 12 Panel AMP BAR BZD COC MET MOR MTD OXY PCP TCA THC XTC
CONFIRM BIOSCIENCES, INC.
RO-DR0012
In Commercial Distribution

  • 00895330002394 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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