microINR ® Link Kit

GUDID 08436540290915

ILINE MICROSYSTEMS SL

Coagulation analyser IVD, home-use, battery-powered

• Primary Device ID: 08436540290915
• NIH Device Record Key: e065d93a-5b99-49a3-bdb3-6cefd2183bcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microINR ® Link Kit
• Version Model Number: KTL0001AD
• Company DUNS: 460067955
• Company Name: ILINE MICROSYSTEMS SL
• 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: true
• 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	08436540290915 [Direct Marking]
GS1	08436540291134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231711

FDA Product Code

• GJS: Test, Time, Prothrombin

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: 2024-08-12
• Device Publish Date: 2024-08-02

On-Brand Devices [microINR ® Link Kit]

• 08436540290908: KTE0001AD
• 08436540290915: KTL0001AD