ASSURE, Garment, Style B, Size 3

Basic Information

• Brand Name: ASSURE, Garment, Style B, Size 3
• Primary DI: 00840241600146
• Version / Model: 80016-003
• Catalog Number: 80016-003
• Company Name: Kestra Medical Technologies, Inc.
• Labeler DUNS: 060944361
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-15
• Public Version: 2
• Public Version Date: 2022-01-12
• Public Version Status: Update
• Public Device Record Key: a071885e-7515-4ff8-aeac-bab4baae4b8e

Device Description

The Style B, Size 3, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.

Device Characteristics

• Single Use: Yes
• 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
MVK	Wearable Automated External Defibrillator	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
48052	Wearable defibrillation system defibrillator	A portable, battery-powered defibrillator carried by a patient, typically in a shoulder bag, and connected to the body-worn electrodes within the vest of a wearable defibrillation system. It continuously monitors the patient's heart rhythms for the detection of life-threatening arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) and alerts the patient prior to electrical treatment shock delivery, allowing a conscious patient to disarm the treatment shock; should the patient be unconscious the defibrillator activates the electrodes (release of their gel) and delivers the shock to restore normal rhythm.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840241600146	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P200037	000
P200037	001
P200037	002
P200037	003

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Style B, Size 3

Storage Conditions

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