ASSURE, Battery 3322882-005

GUDID 00840241600009

A rechargeable battery that powers the ASSURE System

Kestra Medical Technologies, Inc.

Wearable defibrillation system defibrillator
Primary Device ID00840241600009
NIH Device Record Key09504411-2a48-4b88-8b8b-2dc12094845c
Commercial Distribution StatusIn Commercial Distribution
Brand NameASSURE, Battery
Version Model Number3322882-005
Catalog Number3322882-005
Company DUNS060944361
Company NameKestra Medical Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

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

Operating and Storage Conditions

Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840241600009 [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.

00840241600399 - Kestra Provided Device Patient Application2025-05-08 ASSURE Patient Application for the Kestra Provided Device.
00840241600313 - ASSURE Wearable ECG2024-09-26 A wearable cardiac episode recorder
00840241600320 - Battery 2024-09-26 A rechargeable battery that powers the ASSURE Wearable ECG
00840241600337 - System Cable2024-09-26 Provides the connection between an ASSURE Garment and a Battery
00840241600344 - ASSURE Assist Service2024-09-26 The Event Response System (ERS) is a software-only powered communication system that informs a remote user responder of the occu
00840241600382 - Kestra Provided Device Patient Application2024-09-26 ASSURE Patient Application for the Kestra Provided Device.
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.
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