Assure PT Care PT/INR Monitoring System 350222

GUDID 00850040656022

Assure PT Care PT/INR Monitoring System

COAGUSENSE INC.

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

• Primary Device ID: 00850040656022
• NIH Device Record Key: e73fff67-dcc7-4ef7-b865-067bd121f911
• Commercial Distribution Discontinuation: 2023-05-22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assure PT Care PT/INR Monitoring System
• Version Model Number: 350222
• Catalog Number: 350222
• Company DUNS: 007943352
• Company Name: COAGUSENSE INC.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	00850040656022 [Primary]
GS1	10850040656029 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183255

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: 2023-04-14
• Device Publish Date: 2023-04-06

Devices Manufactured by COAGUSENSE INC.

• 00850040656022 - Assure PT Care PT/INR Monitoring System: 2023-04-14Assure PT Care PT/INR Monitoring System
• 00850040656022 - Assure PT Care PT/INR Monitoring System: 2023-04-14 Assure PT Care PT/INR Monitoring System
• 00850040656039 - Assure PT Care Test Strip Kit: 2023-04-14 Arkray Assure PT Care Test Strip, 50 Count
• 00860007370861 - Coag-sense: 2021-10-08 Coag-Sense PT/INR Professional 3-Box Promo
• 00860007370878 - Coag-sense: 2021-10-08 Coag-Sense PT/INR Professional 5-Box Promo
• 10861900000395 - Coag-Sense Test Strip Kit, 50 ct.: 2021-09-17 Test Strip Kit, 50 ct.
• 00861900000350 - Coag-Sense PT/INR Meter: 2019-04-11 Coag-Sense PT/INR Meter
• 00861900000374 - Coag-Sense PT/INR Professional System: 2019-04-11 Coag-Sense PT/INR Professional System
• 00861900000381 - Coag-Sense PT/INR Patient Self-Test System: 2019-04-11 Coag-Sense PT/INR Patient Self-Test System