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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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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

Haemonetics - 20887691312384

Transfer Bag 400ml with 6 Leads
HAEMONETICS CORPORATION
732-42M
In Commercial Distribution

  • 30887691312381 ()
  • 20887691312384 ()

  • Total Volume: 400 Milliliter


  • Blood/tissue storage/culture container

Leukocyte SC RC - 20887691308745

Leukocyte Reduction Filter System for Red Blood Cells with BPF4 High Efficiency Filter, 16-Segment Tubing, Storage Bag and Sample Pouch
HAEMONETICS CORPORATION
430-40
In Commercial Distribution

  • 30887691308742 ()
  • 20887691308745 ()


  • Blood transfusion filter

Haemonetics - 20887691306376

Bacerial Detection System for Quality Control Testing of Platelet Products
HAEMONETICS CORPORATION
400-03
In Commercial Distribution

  • 30887691306373 ()
  • 20887691306376 ()


  • Blood collection set, invasive

Haemonetics - 20887691002957

Single Collection Unit without Anticoagulant
HAEMONETICS CORPORATION
736-21
In Commercial Distribution

  • 30887691002954 ()
  • 20887691002957 ()


  • Blood collection set, invasive

Haemonetics Corporation - 20887691002872

Transfer Bag 1000 ml w/Y Set
HAEMONETICS CORPORATION
732-37M
In Commercial Distribution

  • 30887691002879 ()
  • 20887691002872 ()

  • Total Volume: 1000 Milliliter


  • Blood/tissue storage/culture container

Haemonetics - 20887691002858

Transfer Bag 600 ml w/Y set
HAEMONETICS CORPORATION
732-33M
In Commercial Distribution

  • 30887691002855 ()
  • 20887691002858 ()

  • Total Volume: 600 Milliliter


  • Blood/tissue storage/culture container

Haemonetics - 20887691002841

Transfer Bag 300 ml
HAEMONETICS CORPORATION
732-32M
In Commercial Distribution

  • 30887691002848 ()
  • 20887691002841 ()

  • Total Volume: 300 Milliliter


  • Blood/tissue storage/culture container

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
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