AccessGUDID - DEVICE: ASSURE, Garment, Style A, Size 2 (00840241600061)

GUDID

Device Identifier (DI) Information

Brand Name: ASSURE, Garment, Style A, Size 2
Version or Model: 80015-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80015-002
Company Name: Kestra Medical Technologies, Inc.

Primary DI Number: 00840241600061
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 060944361 *Terms of Use

Device Description: The Style A, Size 2, 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

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVK	Wearable Automated External Defibrillator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P200037	000
P200037	001
P200037	002
P200037	003

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Style A, Size 2

Device Record Status

Public Device Record Key: 7fedea75-46ca-4b30-ad12-04b10d3d48c0
Public Version Date: January 12, 2022
Public Version Number: 2
DI Record Publish Date: November 15, 2021