M Series Biphasic

FDA UDI

Class II (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name: M SERIES BIPHASIC FDA UDI
Generic Name: Physiologic-monitoring defibrillation system FDA UDI
Device Name: Defibrillator ,MAIN,EMTD-1,3/5 LEAD,SPO2,BIPHASIC,EL,PACE,RCD,SMR,CDMK,VOICE,AC,DMST FDA UDI
Model / Reference: 40010211100173010 FDA UDI
Description: Defibrillator ,MAIN,EMTD-1,3/5 LEAD,SPO2,BIPHASIC,EL,PACE,RCD,SMR,CDMK,VOICE,AC,DMST FDA UDI

Identifiers

Primary DI / UDI-DI: 00847946003661 FDA UDI
510(k) Number: K990762 FDA UDI
FDA Product Code: DRO FDA UDI
DPS FDA UDI
MKJ FDA UDI
LDD FDA UDI
GMDN Term: Physiologic-monitoring defibrillation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5550 FDA UDI
870.2340 FDA UDI
870.5310 FDA UDI
870.5300 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

M Series Biphasic 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 afab9336-2d4f-49be-9735-cc70f98aa982 36 fields · synced Jun 8, 2026