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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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PLASMACELL Xi Disposable Set with SPIKESMART - 00810020441116

For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile Fluid Path.
Fresenius Kabi AG
6R2600P
In Commercial Distribution

  • 10810020441113 ()
  • 00810020441116 ()
6R2600P

  • Apheresis system tubing set

Aurora Xi Plasmapheresis System - 00810020440898

Software Version 1.3 for Aurora Xi
Fresenius Kabi AG
1.3
In Commercial Distribution

  • 00810020440898 ()


  • Apheresis system

AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike - 00810020440768

For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator.
Fresenius Kabi AG
4R2359
In Commercial Distribution

  • 10810020440765 ()
  • 00810020440768 ()
4R2359

  • Apheresis system tubing set

Plasmalink Transfer-Pack Container - 2000 mL - 00810020440669

For processing and/or storage of blood and blood components. Sterile Fluid Path.
Fresenius Kabi AG
6R2042
In Commercial Distribution

  • 10810020440666 ()
  • 00810020440669 ()
6R2042

  • Blood/tissue storage/culture container

AMICUS Separator Life Extension Software - 00810020440607

Software version for AMICUS Separator Life Extension Device
Fresenius Kabi AG
6.1.113.0
In Commercial Distribution

  • 00810020440607 ()


  • Apheresis system

AMICUS Separator Legacy Software - 00810020440591

Software version for AMICUS Separator Legacy Device
Fresenius Kabi AG
6.1.13.0
In Commercial Distribution

  • 00810020440591 ()


  • Apheresis system

Aurora Xi - 00810020440560

Aurora Xi Plasmapheresis System with Software Version 2.1
Fresenius Kabi AG
Software Version 2.1
In Commercial Distribution

  • 00810020440560 ()


  • Apheresis system

Aurora Software Version 2.1C Upgrade - 00810020440300

AURORA Software Version 2.1C for collection of plasma by membrane filtration.
Fresenius Kabi AG
Version 2.1C
In Commercial Distribution

  • 00810020440300 ()
  • 10810020440307 ()
X6S4021USB

  • Apheresis system

AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike - 00810020440270

For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator.
Fresenius Kabi AG
4R2358
In Commercial Distribution

  • 10810020440277 ()
  • 00810020440270 ()
4R2358

  • Apheresis system tubing set

AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly - 00810020440164

For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2353G
In Commercial Distribution

  • 10810020440161 ()
  • 00810020440164 ()
4R2353G

  • Apheresis system tubing set

AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly - 00810020440140

For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2354G
In Commercial Distribution

  • 00810020440140 ()
  • 10810020440147 ()
4R2354G

  • Apheresis system tubing set

Aurora Plasmapheresis System Software Version 2.1 - 00810020440003

Aurora Plasmapheresis System Software Version 2.1
Fresenius Kabi AG
SW 2.1
In Commercial Distribution

  • 00810020440003 ()
  • 10810020440000 ()


  • Apheresis system

Tropocells®, Eclipse PRP, Healeon PRP - 07290015874502

No Description
ESTAR TECHNOLOGIES LTD
PPK3B
In Commercial Distribution

  • 07290015874502 ()


  • Haematological concentrate system preparation kit, platelet concentration

Tropocells - 07290015874380

No Description
ESTAR TECHNOLOGIES LTD
ESTSN1650
In Commercial Distribution

  • 07290015874380 ()
ESTSN1650

  • Haematological concentrate system preparation kit, platelet concentration

Tropocells - 07290015874373

No Description
ESTAR TECHNOLOGIES LTD
52FF
In Commercial Distribution

  • 07290015874373 ()
52FF

  • Haematological concentrate system preparation kit, platelet concentration

Tropocells - 07290015874359

No Description
ESTAR TECHNOLOGIES LTD
521254US
In Commercial Distribution

  • 07290015874359 ()
521254US

  • Haematological concentrate system preparation kit, platelet concentration

Eclipse PRP, Tropocells - 07290015874328

No Description
ESTAR TECHNOLOGIES LTD
26754E
In Commercial Distribution

  • 07290015874328 ()
26754E

  • Haematological concentrate system preparation kit, platelet concentration

Tropocells - 07290015874311

No Description
ESTAR TECHNOLOGIES LTD
ESTSN1690
In Commercial Distribution

  • 07290015874311 ()
ESTSN1690

  • Haematological concentrate system preparation kit, platelet concentration

Tropocells - 07290015874229

No Description
ESTAR TECHNOLOGIES LTD
1253VTSF10
Not in Commercial Distribution

  • 07290015874229 ()
1253VTSF10

  • Haematological concentrate system preparation kit, platelet concentration

Tropocells - 07290015874137

No Description
ESTAR TECHNOLOGIES LTD
14992905GLA
In Commercial Distribution

  • 07290015874137 ()
14992905GLA

  • Haematological concentrate system preparation kit, platelet concentration

Tropocells - 07290015874120

No Description
ESTAR TECHNOLOGIES LTD
12991402GLA
In Commercial Distribution

  • 07290015874120 ()
12991402GLA

  • Haematological concentrate system preparation kit, platelet concentration

Tropocells®, Eclipse PRP, Healeon PRP - 07290015874014

No Description
ESTAR TECHNOLOGIES LTD
12531102GLVAS
In Commercial Distribution

  • 07290015874014 ()
12531102GLVAS

  • Haematological concentrate system preparation kit, platelet concentration

Segment Sampler (SEG) - 19555240401332

SEG is intended to aid extraction of a biological fluid sample from a segmented piece of tubing.
ITL ASIA PACIFIC SDN. BHD.
A200200
Not in Commercial Distribution

  • 19555240401349 ()
  • 19555240401332 ()
  • 19555240401356 ()
A200200

  • Blood donor bag segment sampling IVD

DonorCare® Needle Guard Large Channel - 19555240400151

DonorCare® Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
ITL ASIA PACIFIC SDN. BHD.
A100150
In Commercial Distribution

  • 09555240400154 ()
  • 19555240400151 ()
A100150

  • Needle guard

DonorCare® Needle Guard Small Channel - 19555240400137

DonorCare Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
ITL ASIA PACIFIC SDN. BHD.
A100100
In Commercial Distribution

  • 09555240400130 ()
  • 19555240400137 ()
A100100

  • Needle guard

Neg Control - 23661562105438

Negative control reagent for Anti-D Monoclonal Blood Grouping Reagents (210524-210525-210526) for manual tube technique
DIAGAST
210543
In Commercial Distribution

  • 23661562105438 ()
  • 13661562105431 ()
210543

  • Antisera matrix (non-reactive) IVD, control

StemTrol Control Cells - 15099590762896

StemTrol Control Cells
Beckman Coulter, Inc.
IM3632US
In Commercial Distribution

  • 15099590762896 ()
IM3632US

  • Fixative, Orth's solution
  • Multiple CD cell marker IVD, control

PXP - 00886368001015

PXP Disposable Cartridge
Thermogenesis Corp.
80088
In Commercial Distribution

  • 00886368000155 ()
  • 00886368001015 ()


  • Blood centrifugation system containment kit

PXP - 00886368000971

PXP Disposable Cartridge
Thermogenesis Corp.
80088
In Commercial Distribution

  • 00886368000971 ()


  • Blood centrifugation system containment kit

PXP - 00886368000964

PXP Disposable Cartridge
Thermogenesis Corp.
80087
In Commercial Distribution

  • 00886368000155 ()
  • 00886368000964 ()


  • Blood centrifugation system containment kit

PXP - 00886368000711

PXP Disposable Cartridge
Thermogenesis Corp.
80063
In Commercial Distribution

  • 00886368000605 ()
  • 00886368000711 ()


  • Blood centrifugation system containment kit

PXP - 00886368000650

PXP Docking Station
Thermogenesis Corp.
80066
In Commercial Distribution

  • 00886368000643 ()
  • 00886368000650 ()


  • Blood centrifugation system containment kit

PXP - 00886368000636

PXP Control Module
Thermogenesis Corp.
80065
In Commercial Distribution

  • 00886368000629 ()
  • 00886368000636 ()


  • Blood centrifugation system containment kit

AutoXpress Platform Counterbalance CG - 00886368000568

No Description
Thermogenesis Corp.
8-5144
In Commercial Distribution

  • 00886368000568 ()
8-5144

  • Cryobiological storage container

Thermogenesis Start Up Accessory Kit, AXP - 00886368000544

Thermogenesis Start Up Accessory Kit, AXP
Thermogenesis Corp.
8-5100
In Commercial Distribution

  • 00886368000544 ()


  • Blood centrifugation system containment kit

Component Retaining Clip Set, AXP - 00886368000537

AXP Accessory
Thermogenesis Corp.
8-5148
In Commercial Distribution

  • 00886368000537 ()
8-5148

  • Cryobiological storage container

Counterweight, AXP - 00886368000520

AXP Accessory
Thermogenesis Corp.
8-5104
In Commercial Distribution

  • 00886368000520 ()
8-5104

  • Cryobiological storage container

Xpresstrak Software Kit - 00886368000513

AXP Accessory
Thermogenesis Corp.
7-00-288
In Commercial Distribution

  • 00886368000513 ()
7-00-288

  • Cryobiological storage container

AXP Adapter Set, Sorvall 11754/11297 - 00886368000445

No Description
Thermogenesis Corp.
8-5114
In Commercial Distribution

  • 00886368000445 ()
8-5114

  • Cryobiological storage container

AXP Sorval 11754 Bucket Pads - 00886368000438

No Description
Thermogenesis Corp.
8-5155
In Commercial Distribution

  • 00886368000438 ()
8-5155

  • Cryobiological storage container
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