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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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Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and Dual - 00810020441635

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
4R2360
In Commercial Distribution

  • 10810020441632 ()
  • 00810020441635 ()
4R2360

  • Apheresis system tubing set

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

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 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

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
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