Patient Health Software (P.H.S)

GUDID 03665324000067

MAK-SYSTEM GROUP LIMITED

Blood bank information system

• Primary Device ID: 03665324000067
• NIH Device Record Key: 5d4c407d-3340-414a-b5cc-cb691c8d7622
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Health Software (P.H.S)
• Version Model Number: v11.0.0.0
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665324000067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK251188

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: 2025-12-23
• Device Publish Date: 2025-12-15

On-Brand Devices [Patient Health Software (P.H.S)]

• 03665324000005: v2.0
• 03665324000067: v11.0.0.0