LifeVest Wearable Defibrillator
FDA UDIEUDAMEDClass III (US FDA UDI)
Identity
- Trade Name
- LifeVest Wearable Defibrillator, Model 4000 EUDAMEDLifeVest Wearable Defibrillator FDA UDI
- Generic Name
- Wearable defibrillation system FDA UDI
- Device Name
- LifeVest Wearable Defibrillator - Battery Pack EUDAMED
- Model / Reference
- 10A0989 EUDAMEDLifeVest 4000 Battery Pack FDA UDI
Identifiers
- Catalog Number
- 10A0989 FDA UDI
- Primary DI / UDI-DI
- 00855778005036 EUDAMEDFDA UDI
- Basic UDI-DI
- 0855778005P010030BP7X EUDAMED
- Direct Marketing DI
- 00855778005036 EUDAMED
- PMA Number
- P010030 FDA UDI
- FDA Product Code
- MVK FDA UDI
- EMDN Code
- C020480 CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Wearable defibrillation system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Wearable defibrillation system
LifeVest Wearable Defibrillator by ZOLL Manufacturing Corporation — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wearable defibrillation system.
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Cleared under the same submission
P010030 also covers:
- Hospital Wearable Defibrillator — ZOLL Manufacturing Corporation
- Hospital Wearable Defibrillator — ZOLL Manufacturing Corporation
- Hospital Wearable Defibrillator — ZOLL Manufacturing Corporation
- Hospital Wearable Defibrillator — ZOLL Manufacturing Corporation
- LifeVest Wearable Defibrillator — ZOLL Manufacturing Corporation
- LifeVest Wearable Defibrillator — ZOLL Manufacturing Corporation
- LifeVest Wearable Defibrillator — ZOLL Manufacturing Corporation
- LifeVest Wearable Defibrillator — ZOLL Manufacturing Corporation
- LifeVest Wearable Defibrillator — ZOLL Manufacturing Corporation
- LifeVest Wearable Defibrillator — ZOLL Manufacturing Corporation
- LifeVest Wearable Defibrillator — ZOLL Manufacturing Corporation
- LifeVest Wearable Defibrillator — ZOLL Manufacturing Corporation
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- ZOLL Manufacturing Corporation
Sources (2)
- FDA UDI 33346e0e-9801-4b66-8f1e-3380b1d92d37 34 fields · synced Jun 18, 2026
- EUDAMED bfa19d79-4f3a-4ed8-b4e0-1d50d7b6c800 61 fields · synced Jun 18, 2026