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Assure PT Care PT/INR Monitoring System

FDA UDI

Class II (US FDA UDI)

by CoaguSense Inc.

Identity

Trade Name
Assure PT Care PT/INR Monitoring System FDA UDI
Generic Name
Prothrombin time (PT) IVD, kit, rapid clotting, clinical FDA UDI
Device Name
Assure PT Care PT/INR Monitoring System FDA UDI
Model / Reference
350222 FDA UDI
Description
Assure PT Care PT/INR Monitoring System FDA UDI

Identifiers

Catalog Number
350222 FDA UDI
Primary DI / UDI-DI
00850040656022 FDA UDI
510(k) Number
K183255 FDA UDI
FDA Product Code
GJS FDA UDI
GMDN Term
Prothrombin time (PT) IVD, kit, rapid clotting, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7750 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Assure PT Care PT/INR Monitoring System by CoaguSense Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Prothrombin time (PT) IVD, kit, rapid clotting, clinical.

Cleared under the same submission

K183255 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CoaguSense Inc.

Sources (1)

  • FDA UDI e73fff67-dcc7-4ef7-b865-067bd121f911 35 fields · synced Jun 1, 2026