Patient Health Software (P.H.S)

GUDID 03665324000005

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 Blood bank information system

Primary Device ID	03665324000005
NIH Device Record Key	3f2bd3fa-b0c0-4b20-8592-a2af27a41f25
Commercial Distribution Status	In Commercial Distribution
Brand Name	Patient Health Software (P.H.S)
Version Model Number	v2.0
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	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665324000005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

BK180232

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	2023-07-20
Device Publish Date	2023-07-12

Devices Manufactured by MAK-SYSTEM GROUP LIMITED

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