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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QC Sets and Panels: Helix Elite™ Blood Culture Identification (BCID) Control Panel (Inactivated)
MICROBIOLOGICS INC.
8215
Not in Commercial Distribution

  • 70845357041165 ()
8215

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
QC Sets and Panels: KWIK-STIK™ Blood Culture Identification (BCID) Verification Panel (Live Culture)
MICROBIOLOGICS INC.
5229P
Not in Commercial Distribution

  • 70845357038899 ()
5229P

  • Multiple bacteria species culture isolate identification control IVD, kit
10-Panel Urine Dip Panel (MET/MOP/OXY/AMP/BZO/BAR/COC/PCP/MDMA/BUP)
IDUN SOLUTIONS LLC
41511104001034
In Commercial Distribution

  • 90857275007837 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.
Opgen, Inc.
AC042
Not in Commercial Distribution

  • 20812125010062 ()
AC042

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Areta 5 Panel Drug Test Cup (25 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 10810038636990 ()
  • 00810038636993 ()
  • 30855944007278 ()
ACDOA-754-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (6 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 00810038632988 ()
  • 30810038632989 ()
ACDOA-754-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CVi Injector p/n 800620-024 Contents: CVi Injector Head (Siemens), Control Panel, & Power Supply
ACIST MEDICAL SYSTEMS, INC.
014658
In Commercial Distribution

  • 40841716101883 ()


  • Angiography contrast medium injection system, line-powered, mobile
Esteem Synergy®+ Standard Closed End Pouch W/Filter / Two-Sided Comfort Panel / Opaque / Large
CONVATEC, PURCHASING DEPARTMENT
416783
In Commercial Distribution

  • 10768455114693 ()
  • 00768455114696 ()
  • 00768455188703 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Standard Closed End Pouch W/Filter / One-Sided Comfort Panel / Transparent / Large
CONVATEC, PURCHASING DEPARTMENT
416782
In Commercial Distribution

  • 10768455114686 ()
  • 00768455114689 ()
  • 00768455188697 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Mini Closed End Pouch W/Filter / Two-Sided Comfort Panel / Opaque / Medium
CONVATEC, PURCHASING DEPARTMENT
416781
In Commercial Distribution

  • 10768455114679 ()
  • 00768455114672 ()
  • 00768455188680 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Standard Closed End Pouch W/Filter / One-Sided Comfort Panel / Transparent / Medium
CONVATEC, PURCHASING DEPARTMENT
416778
In Commercial Distribution

  • 10768455114648 ()
  • 00768455114641 ()
  • 00768455188659 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Mini Closed End Pouch W/Filter / Two-Sided Comfort Panel / Opaque / Small
CONVATEC, PURCHASING DEPARTMENT
416777
In Commercial Distribution

  • 10768455114631 ()
  • 00768455114634 ()
  • 00768455188642 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Mini Closed End Pouch W/Filter / One-Sided Comfort Panel / Transparent / Small
CONVATEC, PURCHASING DEPARTMENT
416776
In Commercial Distribution

  • 10768455114624 ()
  • 00768455114627 ()
  • 00768455188635 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Standard Closed End Pouch W/Filter / Two-Sided Comfort Panel / Opaque / Small
CONVATEC, PURCHASING DEPARTMENT
416775
In Commercial Distribution

  • 10768455114617 ()
  • 00768455114610 ()
  • 00768455188628 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Standard Closed End Pouch W/Filter / One-Sided Comfort Panel / Transparent / Small
CONVATEC, PURCHASING DEPARTMENT
416774
In Commercial Distribution

  • 10768455114600 ()
  • 00768455114603 ()
  • 00768455188611 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy, 14 in., Drainable Pouch with 1 Sided Comfort Panel, Transparent, Straight, Extra-Large
CONVATEC, PURCHASING DEPARTMENT
405406
Not in Commercial Distribution

  • 10768455104779 ()
  • 00768455104772 ()
  • 80768455104778 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Mini Pouch, Opaque with One Sided Comfort Panel, 2 1/4 in
CONVATEC, PURCHASING DEPARTMENT
401532
Not in Commercial Distribution

  • 10768455103499 ()
  • 00768455103492 ()
  • 80768455103498 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Mini Pouch, Opaque with One Sided Comfort Panel, 1 3/4 in
CONVATEC, PURCHASING DEPARTMENT
401531
Not in Commercial Distribution

  • 10768455103482 ()
  • 00768455103485 ()
  • 80768455103481 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Mini Pouch, Opaque with One Sided Comfort Panel, 1 1/2 in
CONVATEC, PURCHASING DEPARTMENT
401530
Not in Commercial Distribution

  • 10768455103475 ()
  • 00768455103478 ()
  • 80768455103474 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Mini Pouch, Opaque with One Sided Comfort Panel, 1 1/4 in
CONVATEC, PURCHASING DEPARTMENT
401529
Not in Commercial Distribution

  • 10768455103468 ()
  • 00768455103461 ()
  • 80768455103467 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Closed-End Pouch, Opaque with Two Sided Comfort Panel, 2 3/4 in
CONVATEC, PURCHASING DEPARTMENT
401524
Not in Commercial Distribution

  • 10768455103413 ()
  • 00768455103416 ()
  • 80768455103412 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Closed-End Pouch, Opaque with Two Sided Comfort Panel, 2 1/4 in
CONVATEC, PURCHASING DEPARTMENT
401523
Not in Commercial Distribution

  • 10768455103406 ()
  • 00768455103409 ()
  • 80768455103405 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Closed-End Pouch, Opaque with Two Sided Comfort Panel, 1 3/4 in
CONVATEC, PURCHASING DEPARTMENT
401522
Not in Commercial Distribution

  • 10768455103390 ()
  • 00768455103393 ()
  • 80768455103399 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Closed-End Pouch, Opaque with Two Sided Comfort Panel, 1 1/2 in
CONVATEC, PURCHASING DEPARTMENT
401521
Not in Commercial Distribution

  • 10768455103383 ()
  • 00768455103386 ()
  • 80768455103382 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura® Drainable Pouch, 12" Tran W/1-Sided Comfort Panel, 2 3/4"
CONVATEC, PURCHASING DEPARTMENT
401514
In Commercial Distribution

  • 10768455103369 ()
  • 00768455103362 ()
  • 00768455182534 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Drainable Pouch, 12" Tran W/1-Sided Comfort Panel, 2 1/4"
CONVATEC, PURCHASING DEPARTMENT
401513
In Commercial Distribution

  • 10768455103352 ()
  • 00768455103355 ()
  • 00768455182527 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Drainable Pouch, 12" Tran W/1-Sided Comfort Panel, 1 3/4"
CONVATEC, PURCHASING DEPARTMENT
401512
In Commercial Distribution

  • 10768455103345 ()
  • 00768455103348 ()
  • 00768455182510 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Drainable Pouch, 12" Tran W/1-Sided Comfort Panel, 1 1/2"
CONVATEC, PURCHASING DEPARTMENT
401511
In Commercial Distribution

  • 10768455103338 ()
  • 00768455103331 ()
  • 00768455182503 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Drainable Pouch, 12" Tran W/1-Sided Comfort Panel, 1 1/4"
CONVATEC, PURCHASING DEPARTMENT
401510
In Commercial Distribution

  • 10768455103321 ()
  • 00768455103324 ()
  • 00768455182497 ()


  • Multiple-piece urostomy bag, open-ended
Natura+ Urostomy Small Pouch With Soft Tap, Transparent 1-Sided Comfort Panel, 1 1/4"
CONVATEC, PURCHASING DEPARTMENT
421074
Not in Commercial Distribution

  • 10768455133342 ()
  • 00768455133345 ()
  • 00768455189700 ()


  • Multiple-piece urostomy bag, open-ended
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