Sunquest Blood Bank

GUDID 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.

SUNQUEST INFORMATION SYSTEMS, INC.

Blood bank information system application software
Primary Device IDB236BB10010
NIH Device Record Key7f0e8997-27c8-45f6-8faf-676013d00f4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSunquest Blood Bank
Version Model Number10.0.1
Company DUNS052934841
Company NameSUNQUEST INFORMATION SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB236BB10010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MMHBlood Establishment Computer Software And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-15
Device Publish Date2021-03-05

On-Brand Devices [Sunquest Blood Bank]

B236LABBB0Sunquest Blood Bank System
B236LABBB8220Sunquest Blood Bank System
B236LABBB830Sunquest Blood Bank System
B236BB10000Sunquest Blood Bank is intended for use by trained health care professionals responsible for tra
B236BB8230Sunquest Blood Bank is intended for use by trained health care professionals responsible for tra
B236BB8130Sunquest Blood Bank is intended for use by trained health care professionals responsible for tra
B236BB8010Sunquest Blood Bank is intended for use by trained health care professionals responsible for tra
B236BB10010Sunquest Blood Bank is intended for use by trained health care professionals responsible for tra
B236BB10100Sunquest Blood Bank is intended for use by trained health care professionals responsible for tra
B236BB10110Sunquest Blood Bank is intended for use by trained health care professionals responsible for tra
B236BB11000Blood Bank is intended for use by trained health care professionals responsible for transfusion

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