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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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Sunquest Blood Bank - B236BB11020

Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
11.0.2
Not in Commercial Distribution

  • B236BB11020 ()


  • Blood bank information system application software

Sunquest Blood Bank - B236BB11010

Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
11.0.1
Not in Commercial Distribution

  • B236BB11010 ()


  • Blood bank information system application software

Sunquest Blood Bank - B236BB11000

Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
11.0
Not in Commercial Distribution

  • B236BB11000 ()


  • Blood bank information system application software

Sunquest Blood Bank - B236BB10110

Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
10.1.1
Not in Commercial Distribution

  • B236BB10110 ()


  • Blood bank information system application software

Sunquest Blood Bank - B236BB10100

Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
10.1
Not in Commercial Distribution

  • B236BB10100 ()


  • Blood bank information system application software

Sunquest Blood Bank - B236BB10010

Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
10.0.1
Not in Commercial Distribution

  • B236BB10010 ()


  • Blood bank information system application software

Sunquest Blood Bank - B236BB10000

Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
10.0
Not in Commercial Distribution

  • B236BB10000 ()


  • Blood bank information system application software

Viz AAA - 00811852030325

Viz AAA v1.3 (2025-07-13)
VIZ.AI, INC.
Viz AAA Software
In Commercial Distribution

  • 00811852030325 ()


  • Radiology DICOM image processing application software

Viz ICH - 00811852030318

Viz ICH v1.10 (2025-05-05)
VIZ.AI, INC.
Viz ICH Software
In Commercial Distribution



  • Radiology DICOM image processing application software

Viz LVO - 00811852030301

Viz LVO v1.18 (2025-05-04)
VIZ.AI, INC.
Viz LVO Software
In Commercial Distribution



  • Radiology DICOM image processing application software
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