Identity
- Trade Name
- Powerheart® AED G3 Plus Semi Automatic FDA UDI
- Generic Name
- Non-rechargeable public semi-automated external defibrillator FDA UDI
- Device Name
- G3Plus, AED, Semi Automatic, AHA 2010, with adult pads and battery FDA UDI
- Model / Reference
- 9390E-1001 FDA UDI
- Description
- G3Plus, AED, Semi Automatic, AHA 2010, with adult pads and battery FDA UDI
Identifiers
- Catalog Number
- 9390E-1001 FDA UDI
- Primary DI / UDI-DI
- 00812394023325 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- Non-rechargeable public semi-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
MR Unsafe FDA UDI
Category: Non-rechargeable public semi-automated external defibrillator
Powerheart® AED G3 Plus Semi Automatic by Zoll Medical Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-rechargeable public semi-automated external defibrillator.
- samaritan PAD — HEARTSINE TECHNOLOGIES LTD · Class III
- LIFEPAK — PHYSIO-CONTROL, Inc. · Class III
- Powerheart® G3 Pro Battery Charger — Cardiac Science Corporation · Class III
- DDU-100 Lifeline AED with RX form and cabinet — DEFIBTECH, L.L.C. · Class III
- HeartSine Samaritan PAD 450P — HEARTSINE TECHNOLOGIES LTD · Class III
- PHILIPS HeartStart FRx — PHILIPS ELECTRONICS NORTH AMERICA CORPORATION · Class III
- Lifeline View Configuration — DEFIBTECH, L.L.C. · Class III
- Powerheart G5 Kit, Semi, US Eng/ESP LA — Cardiac Science Corporation · Class III
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 9f13ed1c-4151-4f45-8201-3a5b7950b9ab 36 fields · synced Jun 8, 2026