Identity
- Trade Name
- Powerheart® AED G3 Plus Automatic AED FDA UDI
- Generic Name
- Non-rechargeable public automated external defibrillator FDA UDI
- Device Name
- G3 Plus, AED, Automatic, AHA 2010 FDA UDI
- Model / Reference
- 9390A-01 FDA UDI
- Description
- G3 Plus, AED, Automatic, AHA 2010 FDA UDI
Identifiers
- Catalog Number
- 9390A-01 FDA UDI
- Primary DI / UDI-DI
- 00812394021079 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Non-rechargeable public automated external defibrillator
Powerheart® AED G3 Plus Automatic AED 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.
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- LIFEPAK CR2 — PHYSIO-CONTROL, Inc. · Class III
- HeartSine Samaritan PAD 360P — HEARTSINE TECHNOLOGIES LTD · Class III
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- Powerheart® AED G3 Plus Automatic AED — Cardiac Science Corporation · Class III
Cleared under the same submission
K102496 also covers:
- Powerheart® AED G3 Plus Automatic AED — Cardiac Science Corporation
- Powerheart® AED G3 Plus Automatic AED — Cardiac Science Corporation
- Powerheart® AED G3 Plus Automatic AED — Cardiac Science Corporation
- Powerheart® AED G3 Plus Automatic AED — Cardiac Science Corporation
- Powerheart® AED G3 Automatic AED — Zoll Medical Corporation
- Powerheart® AED G3 Automatic AED — Zoll Medical Corporation
- Powerheart® AED G3 Plus Automatic AED — Zoll Medical Corporation
- Powerheart® AED G3 Plus Automatic AED — Zoll Medical Corporation
- Powerheart® AED G3 Plus Automatic AED, stocking package — Zoll Medical Corporation
- Powerheart® AED G3 Plus Semi Automatic — Zoll Medical Corporation
- Powerheart® AED G3 Plus Semi Automatic — Zoll Medical Corporation
- Powerheart® AED G3 Plus Semi Automatic Stocking Package — Zoll Medical Corporation
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zoll Medical Corporation
Sources (1)
- FDA UDI db228284-a366-4d74-b6a5-62c2b990d25f 37 fields · synced Jun 8, 2026