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X Series

FDA UDI

Class III (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name
X SERIES FDA UDI
Generic Name
Rechargeable professional automated external defibrillator FDA UDI
Device Name
X SERIES MONITOR/DEFIBRILLATOR, VOICE, 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, TEMP, CPR EXPANSION PACK AND ETCO2, VOICE, DMST FDA UDI
Model / Reference
601-2431411-01 FDA UDI
Description
X SERIES MONITOR/DEFIBRILLATOR, VOICE, 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, TEMP, CPR EXPANSION PACK AND ETCO2, VOICE, DMST FDA UDI

Identifiers

Primary DI / UDI-DI
00847946063009 FDA UDI
FDA Product Code
MKJ FDA UDI
GMDN Term
Rechargeable professional automated external defibrillator FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Rechargeable professional automated external defibrillator

X Series by Zoll Medical Corporation — Class III — 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 b73998e2-9854-4746-a2a3-f4ce857886cc 34 fields · synced Jun 8, 2026