Coag-sense 03P50-01

GUDID 00861900000329

Coag-Sense PT/INR Patient Self-Test System

COAGUSENSE INC.

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

• Primary Device ID: 00861900000329
• NIH Device Record Key: 6d576a9e-5aac-4736-9911-a0819786b774
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coag-sense
• Version Model Number: 100221
• Catalog Number: 03P50-01
• 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: 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

Customer Support Contacts

• Phone: 1-866-903-0890
• Email: techsupport@coagusense.com
• Phone: 1-866-903-0890
• Email: techsupport@coagusense.com
• Phone: 1-866-903-0890
• Email: techsupport@coagusense.com
• Phone: 1-866-903-0890
• Email: techsupport@coagusense.com
• Phone: 1-866-903-0890
• Email: techsupport@coagusense.com
• Phone: 1-866-903-0890
• Email: techsupport@coagusense.com
• Phone: 1-866-903-0890
• Email: techsupport@coagusense.com
• Phone: 1-866-903-0890
• Email: techsupport@coagusense.com
• Phone: 1-866-903-0890
• Email: techsupport@coagusense.com
• Phone: 1-866-903-0890
• Email: techsupport@coagusense.com
• Phone: 1-866-903-0890
• Email: techsupport@coagusense.com
• Phone: 1-866-903-0890
• Email: techsupport@coagusense.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861900000329 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093243

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: 2018-10-24
• Device Publish Date: 2018-09-23

On-Brand Devices [Coag-sense]

• 00861900000343: Coag-Sense Professional Control Test Strip Kit - 10 Ct
• 00861900000336: Coag-Sense Test Strip Kit - 50 Ct
• 00861900000329: Coag-Sense PT/INR Patient Self-Test System
• 00861900000312: Coag-Sense PT/INR Professional System
• 00861900000305: Coag-Sense PT/INR Meter
• 00860007370878: Coag-Sense PT/INR Professional 5-Box Promo
• 00860007370861: Coag-Sense PT/INR Professional 3-Box Promo