Sunquest Transfusion Manager

GUDID B236TRM3000

Transfusion Manager is a comprehensive software application intended for use by trained healthcare professionals responsible for transfusion services. Transfusion Manager helps users manage the following transfusion service activities: • Positively identify transfusion recipients • Match blood products to recipients • Record recipient pertinent transfusion information • Record recipient transfusion reactions and caregiver comments

SUNQUEST INFORMATION SYSTEMS, INC.

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• Primary Device ID: B236TRM3000
• NIH Device Record Key: 7184168c-1c12-4180-9d19-02775aa106a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunquest Transfusion Manager
• Version Model Number: 3.0
• Company DUNS: 052934841
• Company Name: SUNQUEST INFORMATION SYSTEMS, 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	B236TRM3000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK210556

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: 2021-06-09
• Device Publish Date: 2021-06-01

On-Brand Devices [Sunquest Transfusion Manager]

• B236TRM0: Sunquest Transfusion Manager is blood bank information system application software
• B236TRM2200: Sunquest Transfusion Manager is blood bank information system application software
• B236TRM3000: Transfusion Manager is a comprehensive software application intended for use by trained healthca