microINR ® CHIPS

GUDID 08436540290700

ILINE MICROSYSTEMS SL

Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical

• Primary Device ID: 08436540290700
• NIH Device Record Key: f88821bb-16b1-490b-8653-442d4c0a1e83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microINR ® CHIPS
• Version Model Number: CHC0025AD
• Company DUNS: 460067955
• Company Name: ILINE MICROSYSTEMS SL
• Device Count: 25
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	08436540290700 [Unit of Use]
GS1	08436540290717 [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: 2022-11-28
• 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
• 08436540290700 - microINR ® CHIPS: 2022-11-28
• 08436540290694 - microINR ® Meter: 2021-07-06