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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, 12 Panel CLIA WAIVED Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC + ph,SG,OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATII-71127-A
In Commercial Distribution

  • 00816036020987 ()
  • 00816036021199 ()
STATII-71127-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II, 12 Panel CLIA WAIVED Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC + ph,CR,OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATII-71127-A-CR
In Commercial Distribution

  • 00816036020949 ()
  • 00816036021151 ()
STATII-71127-A-CR

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 12 Panel CLIA Waived Test Cup W/AD, AMP/BARB/BZO/BUP/COC/EDDP/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATII-43147-0-A
In Commercial Distribution

  • 00816036025340 ()
  • 00816036025357 ()
STATII-43147-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel CLIA Waived Click Cup w/ SVT AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, OXY100, PCP25, PPX300, TCA1000, THC50 w/ SVT OX/SG/pH
Instant Technologies, Inc.
ABTDUAW114704D
In Commercial Distribution

  • 30817405023883 ()
  • 00817405023882 ()
  • 10817405023889 ()
ABTDUAW114704D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel CLIA Waived Click Cup w/ SVT AMP1000, BAR300, BUP10, BZO300, COC300, EDDP300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000, THC50 w/ SVT OX/SG/Ph
Instant Technologies, Inc.
ABTDUAW114703C
In Commercial Distribution

  • 30817405023845 ()
  • 00817405023844 ()
  • 10817405023841 ()
ABTDUAW114703C

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans,W/1 Sided Comfort Panel W/Tape Collar, 1 3/4" (45 Mm.
CONVATEC, PURCHASING DEPARTMENT
175784
In Commercial Distribution

  • 10768455102584 ()
  • 00768455102587 ()
  • 00768455181308 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans,W/1 Sided Comfort Panel W/Tape Collar, 1 1/2" (38 Mm.
CONVATEC, PURCHASING DEPARTMENT
175783
In Commercial Distribution

  • 10768455102577 ()
  • 00768455102570 ()
  • 00768455181292 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans,W/1 Sided Comfort Panel W/Tape Collar, 1 3/8" (35 Mm.
CONVATEC, PURCHASING DEPARTMENT
175782
In Commercial Distribution

  • 10768455102560 ()
  • 00768455102563 ()
  • 00768455181285 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans,W/1 Sided Comfort Panel W/Tape Collar, 1 1/4" (32 Mm.
CONVATEC, PURCHASING DEPARTMENT
175781
In Commercial Distribution

  • 10768455102553 ()
  • 00768455102556 ()
  • 00768455181278 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans,W/1 Sided Comfort Panel W/Tape Collar, 1 1/8" (28 Mm.
CONVATEC, PURCHASING DEPARTMENT
175780
In Commercial Distribution

  • 10768455102546 ()
  • 00768455102549 ()
  • 00768455181261 ()


  • One-piece intestinal ostomy bag, closed-ended
Esteem®+ One-Piece Drainable Cut-To-Fit Pouch W/ Invisiclose®, Filter, Modified Stomahesive®, One-Sided Comfort Panel 12" Opaque, 2 2/5" By 2 3/4" (60/70Mm)
CONVATEC, PURCHASING DEPARTMENT
416719
In Commercial Distribution

  • 10768455111890 ()
  • 00768455111893 ()
  • 00768455188345 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Drainable Cut-To-Fit Pouch W/ Invisiclose®, Filter, Modified Stomahesive®, One-Sided Comfort Panel 12" Transparent, 2 2/5" By 2 3/4" (60/70Mm)
CONVATEC, PURCHASING DEPARTMENT
416718
In Commercial Distribution

  • 10768455111883 ()
  • 00768455111886 ()
  • 00768455188338 ()


  • One-piece intestinal ostomy bag, open-ended
The portable and fully digital X-ray system Amadeo M-DR mini is for use for first aid services, intensive care units, emergency departments, as well as ships and mobile hospitals (e.g. container solutions) in inaccessible areas, in laboratories and scientific stations in remote parts of the world. The Amadeo M-DR mini is used for wireless digital X-ray imaging.
Oehm und Rehbein GmbH
Amadeo M-DR mini with Varex flat panel detector
Not in Commercial Distribution

  • 04250802902934 ()
  • 04250802902903 ()

  • Weight: 79 Kilogram
AM1722

  • Mobile basic diagnostic x-ray system, digital
CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek® PA, CardioChek Plus or CardioChek Plus Home Self-Test analyzer.
POLYMER TECHNOLOGY SYSTEMS, INC.
REF 4747
In Commercial Distribution

  • 10381934747016 ()
  • 00381934747019 ()
REF 4747

  • Multiple lipid analyte IVD, kit, spectrophotometry
CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek® PA, CardioChek Plus or CardioChek Plus Home Self-Test analyzer.
POLYMER TECHNOLOGY SYSTEMS, INC.
REF 4749
In Commercial Distribution

  • 00381934749013 ()
REF 4749

  • Multiple lipid analyte IVD, kit, spectrophotometry
No Description
AALTO SCIENTIFIC
K943M-5
In Commercial Distribution

  • B085K943M50 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
AALTO SCIENTIFIC
K942M-5
In Commercial Distribution

  • B085K942M50 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
AALTO SCIENTIFIC
K941M-5
In Commercial Distribution

  • B085K941M50 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
AALTO SCIENTIFIC
K940M-5
In Commercial Distribution

  • B085K940M50 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
AALTO SCIENTIFIC
K919M-5
In Commercial Distribution

  • B085K919M50 ()


  • Total bilirubin IVD, control
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