ASSURE, Carry Pack 3326502-003

GUDID 00840241600207

A portable case that holds the Monitor while wearing the ASSURE system

Kestra Medical Technologies, Inc.

Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator Wearable defibrillation system defibrillator
Primary Device ID00840241600207
NIH Device Record Key0e4922eb-cb03-4be0-9f04-5c4199bd299d
Commercial Distribution StatusIn Commercial Distribution
Brand NameASSURE, Carry Pack
Version Model Number3326502-003
Catalog Number3326502-003
Company DUNS060944361
Company NameKestra Medical Technologies, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
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
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
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
GS100840241600207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MVKWearable Automated External Defibrillator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-23
Device Publish Date2021-11-15

Devices Manufactured by Kestra Medical Technologies, Inc.

00840241600238 - ASSURE WCD System2023-07-04 The ASSURE Wearable Cardioverter Defibrillator System
00840241600283 - ASSURE Patient Application2023-03-21 ASSURE patient app is a component of CareStation.
00840241600306 - CareStation Server2023-03-20 CareStation Server acquires and displays data from the WCD for clinicians to view.
00840241600276 - CareStation Server2023-02-20 CareStation Server acquires and displays data from the WCD for clinicians to view.
00840241600290 - CareStation Server2023-02-20 CareStation Server acquires and displays data from the WCD for clinicians to view.
00840241600252 - ASSURE Patient Application2022-07-04 ASSURE patient app is a component of CareStation.
00840241600269 - CareStation Server2022-06-21 CareStation Server acquires and displays data from the WCD for clinicians to view.
00840241600009 - ASSURE, Battery 2021-11-23 A rechargeable battery that powers the ASSURE System

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