Coag-Sense PT/INR Meter 03P73-01

GUDID 00861900000350

Coag-Sense PT/INR Meter

COAGUSENSE INC.

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

• Primary Device ID: 00861900000350
• NIH Device Record Key: 5aee5983-7171-483a-84bd-453a68b9daa6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coag-Sense PT/INR Meter
• Version Model Number: 200107
• Catalog Number: 03P73-01
• 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: 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

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861900000350 [Primary]

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: 2019-04-11
• Device Publish Date: 2019-04-03

Devices Manufactured by COAGUSENSE INC.

• 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: 2019-04-11Coag-Sense PT/INR Meter
• 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