Assure PT Care PT/INR Monitoring System

Basic Information

• Brand Name: Assure PT Care PT/INR Monitoring System
• Primary DI: 00850040656022
• Version / Model: 350222
• Catalog Number: 350222
• Company Name: COAGUSENSE INC.
• Labeler DUNS: 007943352
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-06
• Public Version: 2
• Public Version Date: 2023-04-25
• Public Version Status: Update
• Public Device Record Key: e73fff67-dcc7-4ef7-b865-067bd121f911

Device Description

Assure PT Care PT/INR Monitoring System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GJS	Test, Time, Prothrombin	Hematology	864.7750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30591	Prothrombin time (PT) IVD, kit, rapid clotting, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative determination of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR), within a short period relative to standard laboratory testing procedures using a clotting method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850040656022	GS1
Package	10850040656029	GS1		10	In Commercial Distribution