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Hospital Wearable Defibrillator

FDA UDI

Class III (US FDA UDI)

by ZOLL Manufacturing Corporation

Identity

Trade Name
Hospital Wearable Defibrillator FDA UDI
Generic Name
Wearable defibrillation system FDA UDI
Model / Reference
HWD 1000 Electrode Cable FDA UDI

Identifiers

Catalog Number
10A0994 FDA UDI
Primary DI / UDI-DI
00855778005203 FDA UDI
PMA Number
P010030 FDA UDI
FDA Product Code
MVK FDA UDI
GMDN Term
Wearable defibrillation system FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Wearable defibrillation system

Hospital Wearable Defibrillator by ZOLL Manufacturing Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wearable defibrillation system.

Cleared under the same submission

P010030 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ZOLL Manufacturing Corporation

Sources (1)

  • FDA UDI d7f6f370-3096-4a5d-878d-99dfa7126177 34 fields · synced Jun 9, 2026