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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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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
The Blood Product Questionnaire Module supports single and/or multi-site blood establishment collection facilities’ creation of a donor history questionnaire, the collection of donor history by donors, the determination of visit requirements, and the determination of donor eligibility through system logic or via analysis by trained facility staff members
BUOY SOFTWARE, LLC
1
In Commercial Distribution

  • 00860010651209 ()


  • Blood bank information system application software
Configurable Software for managing manually entered blood test results.
Rubin & Poor, Inc.
CTS 1.5A
In Commercial Distribution

  • 00860010612866 ()
4

  • Blood bank information system application software
Configurable software for managing manually entered blood test results.
Rubin & Poor, Inc.
QTX - V1.1a(WinSQL 1.0c)
In Commercial Distribution

  • 00860010612859 ()
6

  • Blood bank information system application software
Configurable software for managing automated blood test results.
Rubin & Poor, Inc.
QTX - V1.0e(WinSQL 1.0d)
In Commercial Distribution

  • 00860010612842 ()
5

  • Blood bank information system application software
Configurable Software for managing manually entered blood test results.
Rubin & Poor, Inc.
CTS 1.4A
In Commercial Distribution

  • 00860010612835 ()
4

  • Blood bank information system application software
Configurable software for managing automated blood test results.
Rubin & Poor, Inc.
CTS 1.4A
In Commercial Distribution

  • 00860010612828 ()
3

  • Blood bank information system application software
Configurable software for managing manually entered blood test results.
Rubin & Poor, Inc.
MBC 1.0B
In Commercial Distribution

  • 00860010612811 ()
2

  • Blood bank information system application software
Configurable software for managing automated blood test results.
Rubin & Poor, Inc.
MBC 1.0B
In Commercial Distribution

  • 00860010612804 ()
1

  • Blood bank information system application software
No Description
Blood Bank Computer System
5.0
In Commercial Distribution

  • 00860009119482 ()


  • Blood bank information system application software
No Description
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119468 ()


  • Blood bank information system application software
No Description
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119451 ()


  • Blood bank information system application software
ABO QuickPass is a software application intended to allow donors to complete Computer Assisted Self Interviews (CASI) and computer assisted blood donor registrations. ABO QuickPass works in tandem with compatible blood bank systems to identify repeat donors, retrieve the donor’s donation eligibility, and retrieve the donor history questionnaire appropriate for the donor and intended donation. Upon completion of ABO QuickPass all information which is entered by the donor is transferred to compatible blood bank systems. CASIs can be completed using the Internet via the ABO QuickPass web portal or at the donor site via the ABO QuickPass kiosk. CASIs which are completed via the web portal produce an encrypted barcode, which can be decrypted and imported on the day of donation into the ABO QuickPass kiosk for transfer of question responses to the facilities compatible blood bank system
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119444 ()


  • Blood bank information system application software
No Description
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119437 ()


  • Blood bank information system application software
No Description
Blood Bank Computer System
6.0
In Commercial Distribution

  • 00860009119420 ()


  • Blood bank information system application software
No Description
Blood Bank Computer System
2.0.0
In Commercial Distribution

  • 00860009119406 ()


  • Blood bank information system application software
Autologous Platelet System-PRFM x 2
Musculoskeletal Transplant Foundation, Inc.
910048
Not in Commercial Distribution

  • 00859070006043 ()
910048

  • Haematological concentrate system preparation kit, platelet concentration
Autologous Platelet System - PRP X 2
Musculoskeletal Transplant Foundation, Inc.
910047
Not in Commercial Distribution

  • 00859070006029 ()
910047

  • Haematological concentrate system preparation kit, platelet concentration
Autologous Platelet System Membrane
Musculoskeletal Transplant Foundation, Inc.
910044
Not in Commercial Distribution

  • 00859070006012 ()
910044

  • Haematological concentrate system preparation kit, platelet concentration
Autologous Platelet System - RPR
Musculoskeletal Transplant Foundation, Inc.
910046
Not in Commercial Distribution

  • 00859070006005 ()
910046

  • Haematological concentrate system preparation kit, platelet concentration
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