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Powerheart® AED G3 Plus Automatic AED, stocking package

FDA UDI

Class III (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name
Powerheart® AED G3 Plus Automatic AED, stocking package FDA UDI
Generic Name
Non-rechargeable public automated external defibrillator FDA UDI
Device Name
G3Plus, AED, Automatic ,AHA 2010, with adult pads and battery, stocking package FDA UDI
Model / Reference
9390A-1001SP FDA UDI
Description
G3Plus, AED, Automatic ,AHA 2010, with adult pads and battery, stocking package FDA UDI

Identifiers

Catalog Number
9390A-1001SP FDA UDI
Primary DI / UDI-DI
00812394021093 FDA UDI
510(k) Number
K102496 FDA UDI
FDA Product Code
MKJ FDA UDI
GMDN Term
Non-rechargeable public 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Non-rechargeable public automated external defibrillator

Powerheart® AED G3 Plus Automatic AED, stocking package by Zoll Medical Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-rechargeable public automated external defibrillator.

Cleared under the same submission

K102496 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 850c1db2-35a0-406c-9448-de4575a53cc2 37 fields · synced Jun 6, 2026