Battery

Basic Information

• Brand Name: Battery
• Primary DI: 00840241600320
• Version / Model: 80499-003
• Catalog Number: 80499-003
• Company Name: Kestra Medical Technologies, Inc.
• Labeler DUNS: 060944361
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-18
• Public Version: 1
• Public Version Date: 2024-09-26
• Public Version Status: New
• Public Device Record Key: de4a8aa9-6ba1-4dd0-9ef0-ce9489513fa2

Device Description

A rechargeable battery that powers the ASSURE Wearable ECG

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	870.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62641	Electrocardiograph, home-use	A device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840241600320	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K233864	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius