ASSURE WCD System 80014-002

GUDID 00840241600238

The ASSURE Wearable Cardioverter Defibrillator System

Kestra Medical Technologies, Inc.

Wearable defibrillation system defibrillator
Primary Device ID00840241600238
NIH Device Record Keyc6416f26-e6ad-450a-99d5-ca3d233d852d
Commercial Distribution StatusIn Commercial Distribution
Brand NameASSURE WCD System
Version Model Number80014-002
Catalog Number80014-002
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 Kittrue
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840241600047 [Previous]
GS100840241600238 [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 Date2023-07-04
Device Publish Date2023-06-26

On-Brand Devices [ASSURE WCD System]

00840241600047The ASSURE Wearable Cardioverter Defibrillator System
00840241600238The ASSURE Wearable Cardioverter Defibrillator System

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