AccessGUDID - DEVICE: LifeVest Wearable Defibrillator (00855778005128)

GUDID

Device Identifier (DI) Information

Brand Name: LifeVest Wearable Defibrillator
Version or Model: LifeVest Garment A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10A0991
Company Name: ZOLL MANUFACTURING CORPORATION

Primary DI Number: 00855778005128
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079320559 *Terms of Use

Device Description: No description.

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:	No
Prescription Use (Rx):	No
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?
48051	Wearable defibrillation system	An assembly of devices worn by a patient to continuously monitor the patient's heart rhythms for the detection of life-threatening arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) and to defibrillate the heart (restore normal rhythm) with electrical shocks. Monitoring is performed with dry, non-adhesive electrodes and the patient is alerted by the device prior to electrical shock delivery, allowing a conscious patient to disarm the treatment shock; should the patient be unconscious the system releases gel over the electrodes and delivers a shock. The system consists of a wearable vest containing the electrodes and a portable defibrillator carried by the patient.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVK	Wearable Automated External Defibrillator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P010030	011

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8b2a6e3b-bc21-4897-a68e-27b767b10c48
Public Version Date: March 20, 2025
Public Version Number: 4
DI Record Publish Date: September 24, 2014