ASSURE, Garment, Style B, Size 6 80016-006

GUDID 00840241600177

The Style B, Size 6, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.

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 ID00840241600177
NIH Device Record Key80a5bad3-d49f-4dec-a469-53c072b0cd06
Commercial Distribution StatusIn Commercial Distribution
Brand NameASSURE, Garment, Style B, Size 6
Version Model Number80016-006
Catalog Number80016-006
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 Usetrue
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

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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
GS100840241600177 [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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