Blood Product Administration Module

GUDID 00860475000345

EPIC SYSTEMS CORPORATION

Blood bank information system application software

• Primary Device ID: 00860475000345
• NIH Device Record Key: ee27fb0e-c53d-45da-a7da-e0ac553177cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood Product Administration Module
• Version Model Number: 2
• Company DUNS: 108299124
• Company Name: EPIC SYSTEMS CORPORATION
• 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
GS1	00860475000345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK170032

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: 2023-06-27
• Device Publish Date: 2023-06-19

On-Brand Devices [Blood Product Administration Module]

• 00860475000314: 3
• 00860475000345: 2