ePROGESA

GUDID 03665324000036

MAK-SYSTEM GROUP LIMITED

Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system Blood bank information system

• Primary Device ID: 03665324000036
• NIH Device Record Key: ef54718e-52d4-47b0-a1dd-ee3ed51d57e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ePROGESA
• Version Model Number: 5.0.1
• Company DUNS: 225586757
• Company Name: MAK-SYSTEM GROUP LIMITED
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665324000036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK080002

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: 2023-07-07
• Device Publish Date: 2023-06-29

Devices Manufactured by MAK-SYSTEM GROUP LIMITED

• 03665324000005 - Patient Health Software (P.H.S): 2023-07-20
• 03665324000036 - ePROGESA: 2023-07-07
• 03665324000036 - ePROGESA: 2023-07-07