Kestra Provided Device Patient Application 80740-005

GUDID 00840241600399

ASSURE Patient Application for the Kestra Provided Device.

Kestra Medical Technologies, Inc.

Medical equipment clinical data interfacing software
Primary Device ID00840241600399
NIH Device Record Key01f721c9-8dba-4235-8de1-570d9bd22914
Commercial Distribution StatusIn Commercial Distribution
Brand NameKestra Provided Device Patient Application
Version Model Number80740-005
Catalog Number80740-005
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840241600399 [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 Date2025-05-08
Device Publish Date2025-04-30

On-Brand Devices [Kestra Provided Device Patient Application]

00840241600382ASSURE Patient Application for the Kestra Provided Device.
00840241600399ASSURE Patient Application for the Kestra Provided Device.

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