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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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Dried Blood Spot Kit, Two Card, Modern Health Only
AERO-MED, LLC
CA16350A
Not in Commercial Distribution

  • 50885380164253 ()
  • 10885380164255 ()
CA16350A

  • Phlebotomy kit
Prostate Biopsy Transport Kit, 16 Slot, South County Hospital Healthcare System Only
AERO-MED, LLC
CA19075
Not in Commercial Distribution

  • 50885380164147 ()
  • 10885380164149 ()
CA19075

  • Blood/tissue storage/culture container
Blood Culture Collection Kit, Baptist Medical Center South Only
AERO-MED, LLC
CA15850
Not in Commercial Distribution

  • 50885380164130 ()
  • 10885380164132 ()
CA15850

  • Phlebotomy kit
Blood Culture Collection Kit 23G Set, Grady Hospital Only
AERO-MED, LLC
CA15350
Not in Commercial Distribution

  • 50885380164123 ()
  • 10885380164125 ()
CA15350

  • Phlebotomy kit
Blood Culture Collection Kit, 21G Set, Grady Hospital Only
AERO-MED, LLC
CA15325
Not in Commercial Distribution

  • 50885380164116 ()
  • 10885380164118 ()
CA15325

  • Phlebotomy kit
Urine Collection Kit, North Kansas City Hospital Only
AERO-MED, LLC
CA2625A
Not in Commercial Distribution

  • 50885380164109 ()
  • 10885380164101 ()
CA2625A

  • Urine specimen collection kit IVD
Wet Preparation Specimen Collection Kit, John Hopkins Health System
AERO-MED, LLC
CA7900
In Commercial Distribution

  • 50885380164093 ()
  • 10885380164095 ()
CA7900

  • General specimen receptacle transport container
CARDIOVASCULAR SPLIT PACK
Cardinal Health 200, LLC
29157
In Commercial Distribution

  • 50885380164079 ()
  • 10885380164088 ()
29157

  • Patient surgical drape, single-use
Cardiovascular Split Drape
Cardinal Health 200, LLC
9157
In Commercial Distribution

  • 10885380164064 ()
  • 50885380164055 ()
9157

  • Patient surgical drape, single-use
IV Blood Culture Collection Kit, Trinity Medical Center Only
AERO-MED, LLC
CA16925
Not in Commercial Distribution

  • 50885380163904 ()
  • 10885380163906 ()
CA16925

  • Phlebotomy kit
Venous Blood Culture Collection Kit, Trinity Medical Center Only
AERO-MED, LLC
CA16450
Not in Commercial Distribution

  • 50885380163836 ()
  • 10885380163838 ()
CA16450

  • Phlebotomy kit
Blood Bank Saline Buffered 10L
Cardinal Health 200, LLC
CH3158-8
In Commercial Distribution

  • 10885380163692 ()
CH3158-8

  • Red cell antibody diluent IVD, reagent
Blood Bank Saline Unbuffered 10L
Cardinal Health 200, LLC
CH3158-3
In Commercial Distribution

  • 10885380163685 ()
CH3158-3

  • Red cell antibody diluent IVD, reagent
Blood Bank Saline Buffered 20L
Cardinal Health 200, LLC
CH3158-6
In Commercial Distribution

  • 10885380163678 ()
CH3158-6

  • Red cell antibody diluent IVD, reagent
Blood Bank Saline Unbuffered 20L
Cardinal Health 200, LLC
CH3158-1
In Commercial Distribution

  • 10885380163661 ()
CH3158-1

  • Red cell antibody diluent IVD, reagent
Collection and Transport Swab Microorganism Collection and Transport System
Cardinal Health 200, LLC
C8552-13S
In Commercial Distribution

  • 20885380163569 ()
  • 10885380163562 ()
  • 50885380163560 ()
C8552-13S

  • General specimen collection kit IVD, clinical
Collection and Transport Swab Microorganism Collection and Transport System
Cardinal Health 200, LLC
C8552-13D
In Commercial Distribution

  • 20885380163552 ()
  • 10885380163555 ()
  • 50885380163553 ()
C8552-13D

  • General specimen collection kit IVD, clinical
Collection and Transport Swab Microorganism Collection and Transport System
Cardinal Health 200, LLC
C8552-12S
In Commercial Distribution

  • 20885380163545 ()
  • 10885380163548 ()
  • 50885380163546 ()
C8552-12S

  • General specimen collection kit IVD, clinical
Collection and Transport Swab Microorganism Collection and Transport System
Cardinal Health 200, LLC
C8552-12D
In Commercial Distribution

  • 20885380163538 ()
  • 10885380163531 ()
  • 50885380163539 ()
C8552-12D

  • General specimen collection kit IVD, clinical
Collection and Transport Swab Microorganism Collection and Transport System
Cardinal Health 200, LLC
C8552-11W
In Commercial Distribution

  • 20885380163521 ()
  • 10885380163524 ()
  • 50885380163522 ()
C8552-11W

  • General specimen collection kit IVD, clinical
Collection and Transport Swab Microorganism Collection and Transport System
Cardinal Health 200, LLC
C8552-11S
In Commercial Distribution

  • 20885380163514 ()
  • 10885380163517 ()
  • 50885380163515 ()
C8552-11S

  • General specimen collection kit IVD, clinical
Collection and Transport Swab Microorganism Collection and Transport System
Cardinal Health 200, LLC
C8552-11D
In Commercial Distribution

  • 20885380163507 ()
  • 10885380163500 ()
  • 50885380163508 ()
C8552-11D

  • General specimen collection kit IVD, clinical
Blood Collection Kit, Dried Blood Spot Kit, 2 Card, Modern Health Only
AERO-MED, LLC
CA16350
Not in Commercial Distribution

  • 50885380163164 ()
  • 10885380163166 ()
CA16350

  • Phlebotomy kit
Blood Culture Collection Kit, CHI Saint Vincent Infirmary Only
AERO-MED, LLC
CA10525
In Commercial Distribution

  • 50885380163157 ()
  • 10885380163159 ()
CA10525

  • Phlebotomy kit
Pediatric Blood Collection Kit, The Ohio State University Only
AERO-MED, LLC
CA18275
Not in Commercial Distribution

  • 50885380163140 ()
  • 10885380163142 ()
CA18275

  • Phlebotomy kit
Line Draw Blood Collection Kit, The Ohio State University Only
AERO-MED, LLC
CA17675
Not in Commercial Distribution

  • 50885380163133 ()
  • 10885380163135 ()
CA17675

  • Phlebotomy kit
Adult Blood Culture Kit, The Ohio State University Only
AERO-MED, LLC
CA14725
Not in Commercial Distribution

  • 50885380163126 ()
  • 10885380163128 ()
CA14725

  • Phlebotomy kit
Blood Collection Kit, Dried Blood Spot Kit, One Card, Modern Health Only
AERO-MED, LLC
CA18350
Not in Commercial Distribution

  • 50885380163119 ()
  • 10885380163111 ()
CA18350

  • Phlebotomy kit
Pediatric Pack
Cardinal Health 200, LLC
29490
In Commercial Distribution

  • 50885380162884 ()
  • 10885380162886 ()
29490

  • General surgical procedure kit, non-medicated, single-use
Blood Bank Saline Unbuffered 4L
Cardinal Health 200, LLC
CH3158-2
In Commercial Distribution

  • 50885380162471 ()
  • 10885380162473 ()
CH3158-2

  • Red cell antibody diluent IVD, reagent
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