X Series

FDA UDI

Class II (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name: X SERIES FDA UDI
Generic Name: Physiologic-monitoring defibrillation system FDA UDI
Device Name: X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12-LEAD W/INTERP, PACE, SPO2, SPCO, ETCO2, BVM, TEMP, NIBP, CPR EXPANSION PACK, US, NON-CLINICAL FDA UDI
Model / Reference: 630-2231211-01-68 FDA UDI
Description: X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12-LEAD W/INTERP, PACE, SPO2, SPCO, ETCO2, BVM, TEMP, NIBP, CPR EXPANSION PACK, US, NON-CLINICAL FDA UDI

Identifiers

Primary DI / UDI-DI: 00847946030506 FDA UDI
510(k) Number: K112432 FDA UDI
FDA Product Code: DSK FDA UDI
DRO FDA UDI
CCK FDA UDI
DRT FDA UDI
DQA FDA UDI
MKJ FDA UDI
GMDN Term: Physiologic-monitoring defibrillation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1110 FDA UDI
870.5550 FDA UDI
868.1400 FDA UDI
870.2300 FDA UDI
870.2700 FDA UDI
870.5310 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Physiologic-monitoring defibrillation system

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

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Zoll Medical Corporation

Sources (1)

FDA UDI 25cd414a-245d-40e9-80fb-d8db9710bddc 36 fields · synced Jun 8, 2026