ASSURE Patient Application 80429-003

GUDID 00840241600252

ASSURE patient app is a component of CareStation.

Kestra Medical Technologies, Inc.

Medical equipment clinical data interfacing software
Primary Device ID00840241600252
NIH Device Record Keya10b927d-dade-4826-bcfa-47f40b187af6
Commercial Distribution StatusIn Commercial Distribution
Brand NameASSURE Patient Application
Version Model Number80429-003
Catalog Number80429-003
Company DUNS060944361
Company NameKestra Medical Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1.833.692.7787
Emailxx@xx.xx
Phone1.833.692.7787
Emailxx@xx.xx
Phone1.833.692.7787
Emailxx@xx.xx
Phone1.833.692.7787
Emailxx@xx.xx
Phone1.833.692.7787
Emailxx@xx.xx
Phone1.833.692.7787
Emailxx@xx.xx
Phone1.833.692.7787
Emailxx@xx.xx
Phone1.833.692.7787
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100840241600214 [Previous]
GS100840241600252 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-04
Device Publish Date2022-06-24

On-Brand Devices [ASSURE Patient Application]

00840241600214ASSURE patient app is a component of the ASSURE WCD System and transmits information to CareStat
00840241600252ASSURE patient app is a component of CareStation.
00840241600283ASSURE patient app is a component of CareStation.

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