FDA.reportPublic FDA data

LifeVest Wearable Defibrillator

Primary DI
00855778005449
Brand
LifeVest Wearable Defibrillator
Company
ZOLL MANUFACTURING CORPORATION
Model
LifeVest Garment B (2.4)
Catalog number
10A1096
Published
2024-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
MVKWearable Automated External Defibrillator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVKWearable Automated External DefibrillatorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P010030164

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010030164WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVESTZoll Manufacturing Corporation2001-12-18MVK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855778005449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855778005449008557780054498557780054490855778005449

GMDN Terms#

Term, Definition table
TermDefinition
Wearable defibrillation systemAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079320559
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855778005272Hospital Wearable DefibrillatorHWD 1000 Therapy Electrode10A10092017-06-13
00855778005456uCor Heart Failure and Arrhythmia Management SystemGateway (4G)10A11072023-06-22
00855778005463ZOLL Arrhythmia Management SystemGateway (4G)10A11122023-06-22
00855778005357ZOLL Arrhythmia Management SystemSensor10A10872020-10-21
00855778005364ZOLL Arrhythmia Management SystemGateway10A10882020-10-21
00855778005258ZOLL PatchPatch10A10672019-05-17
00855778005302uCor Heart Failure and Arrhythmia Management SystemSensor10A10712019-05-17
00855778005319ZOLL ChargerCharger10A10722019-05-17
00855778005326uCor Heart Failure and Arrhythmia Management SystemGateway10A10732019-05-17
00855778005432LifeVest Wearable DefibrillatorLifeVest Garment B (2.3)10A10952024-08-21
00855778005371LifeVest Wearable DefibrillatorLifeVest 5100 Monitor10A10822024-08-19
00855778005388LifeVest Wearable DefibrillatorLifeVest 5100 Electrode Belt10A10862024-08-19
00855778005395LifeVest Wearable DefibrillatorLifeVest 5100 Battery Charger10A10832024-08-19
00855778005401LifeVest Wearable DefibrillatorLifeVest 5100 Battery Pack10A10842024-08-19
00855778005210LifeVest Wearable DefibrillatorLifeVest 4000 Battery Charger10A10432020-08-11
00855778005005LifeVest Wearable DefibrillatorLifeVest 4000 Monitor10A09882014-09-24
00855778005012LifeVest Wearable DefibrillatorLifeVest 4000 Electrode Belt10A09872014-09-24
00855778005029LifeVest Wearable DefibrillatorLifeVest 4000 Battery Charger10A09852014-09-24
00855778005036LifeVest Wearable DefibrillatorLifeVest 4000 Battery Pack10A09892014-09-24
00855778005043LifeVest Wearable DefibrillatorLifeVest 3000 Battery Pack10A08942015-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850047782052Jewel Mobile AppElement Science, Inc.MVK2026-05-04
00850047782168Jewel Mobile AppElement Science, Inc.MVK2026-05-04
00840241600375ASSURE WCD SystemKestra Medical Technologies, Inc.MVK2026-04-15
00840241600405ASSURE, MonitorKestra Medical Technologies, Inc.MVK2026-04-15
00850047782007"Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (""Jewel"")"Element Science, Inc.MVK2025-05-12
00850047782038Jewel Starter KitElement Science, Inc.MVK2025-05-12
00850047782090Jewel PatchElement Science, Inc.MVK2025-05-12
00855778005432LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-21
00855778005371LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-19
00855778005388LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-19
00855778005395LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-19
00855778005401LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-19
00840241600238ASSURE WCD SystemKestra Medical Technologies, Inc.MVK2023-06-26
00840241600221ASSURE, MonitorKestra Medical Technologies, Inc.MVK2022-12-09
00840241600245ASSURE, TabletKestra Medical Technologies, Inc.MVK2022-12-09
00840241600009ASSURE, Battery Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600016ASSURE, ChargerKestra Medical Technologies, Inc.MVK2021-11-15
00840241600023ASSURE, Therapy CableKestra Medical Technologies, Inc.MVK2021-11-15
00840241600030ASSURE, MonitorKestra Medical Technologies, Inc.MVK2021-11-15
00840241600047ASSURE WCD SystemKestra Medical Technologies, Inc.MVK2021-11-15
00840241600054ASSURE, Garment, Style A, Size 1Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600061ASSURE, Garment, Style A, Size 2Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600078ASSURE, Garment, Style A, Size 3Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600085ASSURE, Garment, Style A, Size 4Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600092ASSURE, Garment, Style A, Size 5Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600108ASSURE, Garment, Style A, Size 6Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600115ASSURE, Garment, Style A, Size 7Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600122ASSURE, Garment, Style B, Size 1Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600139ASSURE, Garment, Style B, Size 2Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600146ASSURE, Garment, Style B, Size 3Kestra Medical Technologies, Inc.MVK2021-11-15