Sunquest Blood Bank

GUDID 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

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• Primary Device ID: B236BB11010
• NIH Device Record Key: 0a3ba609-2916-41cb-b0a2-d1df48962bd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunquest Blood Bank
• Version Model Number: 11.0.1
• Company DUNS: 052934841
• Company Name: CliniSys, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B236BB11010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK160005

FDA Product Code

• MMH: Blood Establishment Computer Software And Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-11
• Device Publish Date: 2022-11-03

On-Brand Devices [Sunquest Blood Bank]

• B236LABBB8210: Sunquest Blood Bank System
• B236BB11010: Blood Bank is intended for use by trained health care professionals responsible for transfusion
• B236BB11020: Blood Bank is intended for use by trained health care professionals responsible for transfusion