ASSURE, Monitor 80008-003

GUDID 00840241600030

A part of the ASSURE System that provides power and displays system status information

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 ID: 00840241600030
• NIH Device Record Key: 6e3e421b-96e6-46bb-8ad1-b724113ab6b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSURE, Monitor
• Version Model Number: 80008-003
• Catalog Number: 80008-003
• Company DUNS: 060944361
• Company Name: Kestra Medical Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840241600030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200037

FDA Product Code

• MVK: Wearable Automated External Defibrillator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-23
• Device Publish Date: 2021-11-15

Devices Manufactured by Kestra Medical Technologies, Inc.

• 00840241600238 - ASSURE WCD System: 2023-07-04 The ASSURE Wearable Cardioverter Defibrillator System
• 00840241600283 - ASSURE Patient Application: 2023-03-21 ASSURE patient app is a component of CareStation.
• 00840241600306 - CareStation Server: 2023-03-20 CareStation Server acquires and displays data from the WCD for clinicians to view.
• 00840241600276 - CareStation Server: 2023-02-20 CareStation Server acquires and displays data from the WCD for clinicians to view.
• 00840241600290 - CareStation Server: 2023-02-20 CareStation Server acquires and displays data from the WCD for clinicians to view.
• 00840241600252 - ASSURE Patient Application: 2022-07-04 ASSURE patient app is a component of CareStation.
• 00840241600269 - CareStation Server: 2022-06-21 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