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E Series

FDA UDI

Class III (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name
E SERIES FDA UDI
Generic Name
Rechargeable professional automated external defibrillator FDA UDI
Device Name
Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, W/ RAILS, DMST FDA UDI
Model / Reference
50011830020124012 FDA UDI
Description
Defibrillator ,MAIN, ACLS-1, 12 LEAD, SPO2/SPCO/ETCO2/NIBP, BT/GPS, PACE, AC, LI-ION, W/ RAILS, DMST FDA UDI

Identifiers

Primary DI / UDI-DI
00847946011406 FDA UDI
510(k) Number
K111594 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

E 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.

Cleared under the same submission

K111594 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 09577c74-f05c-4631-b9c1-e659fe2a2f02 36 fields · synced Jun 8, 2026