CLEWICU

GUDID 07290018852002

CLEW MEDICAL LTD

Clinical management support software

• Primary Device ID: 07290018852002
• NIH Device Record Key: 1850af04-1758-4b7a-a74b-11fad52864cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEWICU
• Version Model Number: 4.8
• Company DUNS: 600148544
• Company Name: CLEW MEDICAL LTD
• 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: true
• 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	07290018852002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200717

FDA Product Code

• QNL: Medium-Term Adjunctive Predictive Cardiovascular Indicator

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: 2024-12-17
• Device Publish Date: 2024-12-09