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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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Concentrating System PRP-S 60mL GenesisCS Component Concentrating System - 00855306003053

No Description
EMCYTE CORP.
620-11-09
In Commercial Distribution

  • 00855306003053 ()
620-11-09

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration

Accelerate Platelet Concentrating System PRP-S 60mL - 00855306003046

No Description
EMCYTE CORP.
620-11-08
In Commercial Distribution

  • 00855306003046 ()
620-11-08

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration

Accelerate Platelet Concentrating System PRP-S 30mL - 00855306003039

No Description
EMCYTE CORP.
620-11-06
In Commercial Distribution

  • 00855306003039 ()
620-11-06

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration

Accelerate Platelet Concentrating System PRP-S 30mL - 00855306003022

No Description
EMCYTE CORP.
620-11-07
In Commercial Distribution

  • 00855306003022 ()
620-11-07

  • Haematological concentrate system preparation kit, platelet concentration
  • Haematological concentrate system preparation kit, bone marrow concentration

Accelerate Platelet Concentrating System 60mL - 00855306003015

No Description
EMCYTE CORP.
620-11-02
In Commercial Distribution

  • 00855306003015 ()
620-11-02

  • Haematological concentrate system preparation kit, platelet concentration
  • Haematological concentrate system preparation kit, bone marrow concentration

AbsolutePRP 60mL GenesisCS Component Concentrating System - 00855306003008

No Description
EMCYTE CORP.
GS60
In Commercial Distribution

  • 00855306003008 ()
GS60

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Haematological concentrate system preparation kit, platelet concentration

ProGen PC Kit - 00861122000312

The ProGen PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates high platelet yield in a highly reproducible manner. This is accomplished by inclusion of design elements that provide appropriate directional, and selectable, cell layer aspiration within the horizontally dispersed “buffy coat” in the centrifuge tube design. The design resembles the shape, and general construction, of a standard 50ml centrifuge tube, but differs from such standard products by inclusion of proprietary structural components. The similarities in design allow such devices to be centrifuged in any tabletop centrifuge that accepts a 50ml tube and is, additionally, capable of 1900 RCF at 3500 RPM, 4X50ml capacity and 30-minute timer.
CELLMEDIX HOLDINGS, LLC
BELL-82380-A
In Commercial Distribution

  • 00861122000312 ()
  • 10861122000319 ()
BELL-82380-A

  • Haematological concentrate system preparation kit, platelet concentration

Centripid PC - 00861122000305

The Centrepid PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates high platelet yield in a highly reproducible manner. This is accomplished by inclusion of design elements that provide appropriate directional, and selectable, cell layer aspiration within the horizontally dispersed “buffy coat” in the centrifuge tube design. The design resembles the shape, and general construction, of a standard 50ml centrifuge tube, but differs from such standard products by inclusion of proprietary structural components. The similarities in design allow such devices to be centrifuged in any tabletop centrifuge that accepts a 50ml tube and is, additionally, capable of 1900 RCF at 3500 RPM, 4X50ml capacity and 30-minute timer.
CELLMEDIX HOLDINGS, LLC
CELL-80180-A
In Commercial Distribution

  • 10861122000302 ()
  • 00861122000305 ()
CELL-80180-A

  • Haematological concentrate system preparation kit, platelet concentration

Pall® Freezing Bag 25 mL with Separable Chamber - 00636207302465

25 mL Freezing Bag with Separable Chamber for blood component freezing.
Global Life Sciences Solutions USA LLC
791-05
In Commercial Distribution

  • 30636207302466 ()
  • 00636207302465 ()
  • 20636207302469 ()

  • Total Volume: 25 Milliliter
  • recommended fill volume
791-05

  • Umbilical cord blood collection set

Pall® Transfer/Freezing Bag Set - 00636207302441

Two transfer bags (150 mL and 200 mL) and one 25 mL freezing bag for blood component processing and freezing.
Global Life Sciences Solutions USA LLC
791-02
In Commercial Distribution

  • 30636207302442 ()
  • 00636207302441 ()

  • Total Volume: 25 Milliliter
  • recommended fill volume
791-02

  • Umbilical cord blood collection set
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