microINR ® Meter

GUDID 08436540290694

ILINE MICROSYSTEMS SL

Coagulation analyser IVD, home-use, battery-powered Coagulation analyser IVD, home-use, battery-powered Coagulation analyser IVD, home-use, battery-powered Coagulation analyser IVD, home-use, battery-powered Coagulation analyser IVD, home-use, battery-powered Coagulation analyser IVD, home-use, battery-powered Coagulation analyser IVD, home-use, battery-powered Coagulation analyser IVD, home-use, battery-powered Coagulation analyser IVD, home-use, battery-powered Coagulation analyser IVD, home-use, battery-powered Coagulation analyser IVD, home-use, battery-powered Coagulation analyser IVD, home-use, battery-powered Coagulation analyser IVD, home-use, battery-powered Coagulation analyser IVD, home-use, battery-powered Coagulation analyser IVD, home-use, battery-powered Coagulation analyser IVD, home-use, battery-powered

• Primary Device ID: 08436540290694
• NIH Device Record Key: ca759c6d-cf55-4dd8-9459-a2a859e9e499
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microINR ® Meter
• Version Model Number: KTC0001AD
• 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	08436540290694 [Direct Marking]
GS1	08436540290816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201185

FDA Product Code

• GJS: Test, Time, Prothrombin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-07-06
• Device Publish Date: 2021-05-28

Devices Manufactured by ILINE MICROSYSTEMS SL

• 08436540290908 - microINR ® Link Kit: 2024-04-09
• 08436540290700 - microINR ® CHIPS: 2022-11-28
• 08436540290694 - microINR ® Meter: 2021-07-06
• 08436540290694 - microINR ® Meter: 2021-07-06