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M Series Biphasic

FDA UDI

Class III (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name
M SERIES BIPHASIC FDA UDI
Generic Name
Rechargeable professional automated external defibrillator FDA UDI
Device Name
Defibrillator ,MAIN, EMTD-1,AED,3/5LEAD,BIPHASIC,DC,SPO2,PC,EL,RC,SM,CDMK, ENGLISH FDA UDI
Model / Reference
40010221100163010 FDA UDI
Description
Defibrillator ,MAIN, EMTD-1,AED,3/5LEAD,BIPHASIC,DC,SPO2,PC,EL,RC,SM,CDMK, ENGLISH FDA UDI

Identifiers

Primary DI / UDI-DI
00847946003845 FDA UDI
510(k) Number
K990762 FDA UDI
FDA Product Code
MKJ FDA UDI
DRO FDA UDI
LLD FDA UDI
DPS FDA UDI
GMDN Term
Rechargeable professional automated external defibrillator FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.5310 FDA UDI
870.5550 FDA UDI
880.5965 FDA UDI
870.2340 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

M Series Biphasic 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.

Cleared under the same submission

K990762 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 3d156b5b-42ce-4f05-9387-1b0eb4bfc694 36 fields · synced Jun 8, 2026