Identity
- Trade Name
- Powerheart® G3 Battery FDA UDI
- Generic Name
- Primary battery FDA UDI
- Device Name
- IntelliSense lithium battery (white): For Powerheart AED G3 model 9300E and 9300A shipped after April 12, 2004 with 4 year full replacement guarantee FDA UDI
- Model / Reference
- 9146-301 FDA UDI
- Description
- IntelliSense lithium battery (white): For Powerheart AED G3 model 9300E and 9300A shipped after April 12, 2004 with 4 year full replacement guarantee FDA UDI
Identifiers
- Catalog Number
- 9146-301 FDA UDI
- Primary DI / UDI-DI
- 00812394020874 FDA UDI
- 510(k) Number
- K102496 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- Primary battery 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Primary battery
Powerheart® G3 Battery by Zoll Medical Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 — 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
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 |
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Manufacturer
- Manufacturer
- Zoll Medical Corporation
Sources (1)
- FDA UDI 14bfe207-a8f2-4756-8947-78ce5da202a3 36 fields · synced Jun 8, 2026