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ZOLL Arrhythmia Management System

FDA UDI

Class II (US FDA UDI)

by ZOLL Manufacturing Corporation

Identity

Trade Name
ZOLL Arrhythmia Management System FDA UDI
Generic Name
Wearable multiple vital physiological parameter monitoring system FDA UDI
Model / Reference
Sensor FDA UDI

Identifiers

Catalog Number
10A1087 FDA UDI
Primary DI / UDI-DI
00855778005357 FDA UDI
510(k) Number
K190939 FDA UDI
FDA Product Code
MHX FDA UDI
DSI FDA UDI
GMDN Term
Wearable multiple vital physiological parameter monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1025 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 multiple vital physiological parameter monitoring system

ZOLL Arrhythmia Management System by ZOLL Manufacturing Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wearable multiple vital physiological parameter monitoring system.

Cleared under the same submission

K190939 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 7d19235c-59fb-456c-9320-3c4dacbe4410 34 fields · synced Jun 9, 2026