ASSURE WCD System 80014-001

GUDID 00840241600047

The ASSURE Wearable Cardioverter Defibrillator 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 ID: 00840241600047
• NIH Device Record Key: 1ec079ac-314d-43ad-a010-9bfca975c2a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSURE WCD System
• Version Model Number: 80014-001
• Catalog Number: 80014-001
• Company DUNS: 060944361
• Company Name: Kestra Medical Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• 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	00840241600047 [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

On-Brand Devices [ASSURE WCD System]

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