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 Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical
Primary Device ID00850040656022
NIH Device Record Keye73fff67-dcc7-4ef7-b865-067bd121f911
Commercial Distribution Discontinuation2023-05-22
Commercial Distribution StatusIn Commercial Distribution
Brand NameAssure PT Care PT/INR Monitoring System
Version Model Number350222
Catalog Number350222
Company DUNS007943352
Company NameCOAGUSENSE INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850040656022 [Primary]
GS110850040656029 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GJSTest, Time, Prothrombin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-14
Device Publish Date2023-04-06

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 Kit2023-04-14 Arkray Assure PT Care Test Strip, 50 Count
00860007370861 - Coag-sense2021-10-08 Coag-Sense PT/INR Professional 3-Box Promo
00860007370878 - Coag-sense2021-10-08 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 Meter2019-04-11 Coag-Sense PT/INR Meter
00861900000374 - Coag-Sense PT/INR Professional System2019-04-11 Coag-Sense PT/INR Professional System
00861900000381 - Coag-Sense PT/INR Patient Self-Test System2019-04-11 Coag-Sense PT/INR Patient Self-Test System
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