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Onestep Cpr Ii Adult Multi-Function Electrode, Sin

FDA UDI

Class II (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name
ONESTEP CPR II ADULT MULTI-FUNCTION ELECTRODE, SIN FDA UDI
Generic Name
Rechargeable professional automated external defibrillator FDA UDI
Device Name
ONESTEP ADULT CPR SENSOR, SINGLE FDA UDI
Model / Reference
8900-000350-01 FDA UDI
Description
ONESTEP ADULT CPR SENSOR, SINGLE FDA UDI

Identifiers

Primary DI / UDI-DI
00847946099664 FDA UDI
FDA Product Code
LIX FDA UDI
MKJ FDA UDI
GMDN Term
Rechargeable professional automated external defibrillator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5210 FDA UDI
870.5310 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Rechargeable professional automated external defibrillator

Onestep Cpr Ii Adult Multi-Function Electrode, Sin 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.

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 a83acc35-b2c6-4810-8333-7d35b42fcb0b 35 fields · synced Jun 8, 2026