ASSURE Assist Service 80739-001

GUDID 00840241600344

The Event Response System (ERS) is a software-only powered communication system that informs a remote user responder of the occurrence of a triggering event.

Kestra Medical Technologies, Inc.

Medical equipment clinical data interfacing software

• Primary Device ID: 00840241600344
• NIH Device Record Key: 5ef0e56e-03f3-4720-b420-9fc35ed49fc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSURE Assist Service
• Version Model Number: 80739-001
• Catalog Number: 80739-001
• Company DUNS: 060944361
• Company Name: Kestra Medical Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840241600344 [Primary]

FDA Product Code

• OUG: Medical Device Data System

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.

• 00840241600399 - Kestra Provided Device Patient Application: 2025-05-08 ASSURE Patient Application for the Kestra Provided Device.
• 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: 2024-09-26The Event Response System (ERS) is a software-only powered communication system that informs a remote user responder of the occurrence of a triggering event.
• 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.