ASSURE Wearable ECG 80553-001

GUDID 00840241600313

A wearable cardiac episode recorder

Kestra Medical Technologies, Inc.

Electrocardiograph, home-use

• Primary Device ID: 00840241600313
• NIH Device Record Key: 0dbf56d5-3427-433c-affe-196715ace4da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSURE Wearable ECG
• Version Model Number: 80553-001
• Catalog Number: 80553-001
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840241600313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233864

FDA Product Code

• MWJ: Electrocardiograph, Ambulatory (Without Analysis)

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: 2024-09-26
• Device Publish Date: 2024-09-18

Devices Manufactured by Kestra Medical Technologies, Inc.

• 00840241600313 - ASSURE Wearable ECG: 2024-09-26A wearable cardiac episode recorder
• 00840241600313 - ASSURE Wearable ECG: 2024-09-26 A wearable cardiac episode recorder
• 00840241600320 - Battery: 2024-09-26 A rechargeable battery that powers the ASSURE Wearable ECG
• 00840241600337 - System Cable: 2024-09-26 Provides the connection between an ASSURE Garment and a Battery
• 00840241600344 - ASSURE Assist Service: 2024-09-26 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 Application: 2024-09-26 ASSURE Patient Application for the Kestra Provided Device.
• 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.