LifeVest Wearable Defibrillator 10A0924

GUDID 00855778005050

ZOLL MANUFACTURING CORPORATION

Wearable defibrillation system
Primary Device ID00855778005050
NIH Device Record Key05d2dcfd-07cb-400f-995b-670ecb1a2208
Commercial Distribution StatusIn Commercial Distribution
Brand NameLifeVest Wearable Defibrillator
Version Model NumberLifeVest 3000 Modem
Catalog Number10A0924
Company DUNS079320559
Company NameZOLL MANUFACTURING CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100855778005050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MVKWearable Automated External Defibrillator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-02-27

On-Brand Devices [LifeVest Wearable Defibrillator]

00855778005135LifeVest 4000 Electrode Belt
00855778005128LifeVest Garment A
00855778005111LifeVest Garment B
00855778005050LifeVest 3000 Modem
00855778005043LifeVest 3000 Battery Pack
00855778005036LifeVest 4000 Battery Pack
00855778005029LifeVest 4000 Battery Charger
00855778005012LifeVest 4000 Electrode Belt
00855778005005LifeVest 4000 Monitor
00855778005210LifeVest 4000 Battery Charger

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