AccessGUDID - DEVICE: ASSURE WCD System (00840241600238)

GUDID

Device Identifier (DI) Information

Brand Name: ASSURE WCD System
Version or Model: 80014-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80014-002
Company Name: Kestra Medical Technologies, Inc.

Primary DI Number: 00840241600238
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 060944361 *Terms of Use
Previous DI: 00840241600047

Device Description: The ASSURE Wearable Cardioverter Defibrillator System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	Yes
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

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
No Device Sizes

Device Record Status

Public Device Record Key: c6416f26-e6ad-450a-99d5-ca3d233d852d
Public Version Date: July 04, 2023
Public Version Number: 1
DI Record Publish Date: June 26, 2023