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ZOLL Patch

FDA UDI

Class II (US FDA UDI)

by ZOLL Manufacturing Corporation

Identity

Trade Name
ZOLL Patch FDA UDI
Generic Name
Wearable multiple vital physiological parameter monitoring system FDA UDI
Model / Reference
Patch FDA UDI

Identifiers

Catalog Number
10A1067 FDA UDI
Primary DI / UDI-DI
00855778005258 FDA UDI
510(k) Number
K172510 FDA UDI
K190939 FDA UDI
FDA Product Code
DSB FDA UDI
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
870.2770 FDA UDI
870.1025 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Wearable multiple vital physiological parameter monitoring system

ZOLL Patch 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

K172510 also covers:

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 6f0e9368-cce7-4df3-a249-c1957a702fff 34 fields · synced Jun 9, 2026