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Cuffs

FDA UDI

Class II (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name
Cuffs FDA UDI
Generic Name
Rechargeable professional automated external defibrillator FDA UDI
Device Name
neonate cuffs package level FDA UDI
Model / Reference
9355-1644 FDA UDI
Description
neonate cuffs package level FDA UDI

Identifiers

Primary DI / UDI-DI
10847946021365 FDA UDI
510(k) Number
K120907 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Rechargeable professional automated external defibrillator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Rechargeable professional automated external defibrillator

Cuffs by Zoll Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rechargeable professional automated external defibrillator.

Cleared under the same submission

K120907 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zoll Medical Corporation

Sources (1)

  • FDA UDI 2e25bf86-17ee-46b3-a81d-6af04993024b 35 fields · synced Jun 8, 2026