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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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Celling ART PRP 2-Step Mini Kit - 00817771028870

ART PRP 2-Step Processing Kit - Mini - w/o blood draw
Celling Biosciences
1651-0002
In Commercial Distribution

  • 00817771028870 ()
1651-0002

  • Haematological concentrate system preparation kit, platelet concentration

Celling ART PRP 2-Step 120 Kit - 00817771028856

ART PRP 2-Step Processing Kit - 120
Celling Biosciences
1651-0005
In Commercial Distribution

  • 00817771028856 ()
1651-0005

  • Haematological concentrate system preparation kit, platelet concentration

Celling ART PRP 2-Step 60 Kit - 00817771028825

ART PRP 2-Step Processing Kit - 60
Celling Biosciences
1651-0004
In Commercial Distribution

  • 00817771028825 ()
1651-0004

  • Haematological concentrate system preparation kit, platelet concentration

HAEMONETICS ACP 215 SYSTEM - 10812747015011

RBC DE-GLYCEROL./CELL WASH SET
HAEMONETICS CORPORATION
00235-00
In Commercial Distribution

  • 30812747015015 ()
  • 10812747015011 ()

  • Total Volume: 225 Milliliter
  • Total Volume: 5 Liter
  • Total Volume: 600 Milliliter


  • Blood cell freeze/thaw system set

HAEMONETICS ACP 215 SYSTEM - 10812747015004

RBC GLYCEROLIZATION SET
HAEMONETICS CORPORATION
00225-00
In Commercial Distribution

  • 30812747015008 ()
  • 10812747015004 ()


  • Blood cell freeze/thaw system set

HAEMONETICS PCS 2 APHERESIS SYSTEM - 30812747011970

PCS2, LIST NO,06002-110-EXP-EW
HAEMONETICS CORPORATION
06002-110-EXP-EW
In Commercial Distribution

  • 30812747011970 ()


  • Autotransfusion system blood component processing set

STAT PROFILE - 00385480489034

Stat Profile pHOx Ultra/CCX Blood Gas Controls Auto-Cartridge 6/Day
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA/CCX
In Commercial Distribution

  • 00385480489034 ()
48903

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480356381

STAT PROFILE CRITICAL CARE XPRESS CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
CCX
In Commercial Distribution

  • 00385480356381 ()
  • 00385489356382 ()
35638

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

STAT PROFILE - 00385480489355

Stat Profile pHOx Ultra/CCX Blood Gas Controls Multipack L1, 2, 3 (Amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480489355 ()
  • 00385489489356 ()
48935

  • Assisted reproduction centrifuge tube

STAT PROFILE - 00385480489041

Stat Profile pHOx Ultra/CCX Blood Gas Controls Auto-Cartridge 9/Day
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA/CCX
In Commercial Distribution

  • 00385480489041 ()
48904

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
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