Identity
- Trade Name
- Powerheart® Adult Defibrillation Pads FDA UDI
- Generic Name
- External defibrillation electrode, adult, single-use FDA UDI
- Device Name
- Defibrillation Pads(adult) with two-year shelf life for full range of Powerheart® AEDs FDA UDI
- Model / Reference
- 9131-001 FDA UDI
- Description
- Defibrillation Pads(adult) with two-year shelf life for full range of Powerheart® AEDs FDA UDI
Identifiers
- Catalog Number
- 9131-001 FDA UDI
- Primary DI / UDI-DI
- 00812394020911 FDA UDI
- 510(k) Number
- K102496 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- External defibrillation electrode, adult, single-use 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: External defibrillation electrode, adult, single-use
Powerheart® Adult Defibrillation Pads by Zoll Medical Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External defibrillation electrode, adult, single-use.
- Cardio Clear — CARDIO MEDICAL PRODUCTS, INC. · Class II
- Heartsync by Vermed — GRAPHIC CONTROLS ACQUISITION CORP · Class III
- Intellisense Adult Defibrillation Pads, Powerheart® G5 — Cardiac Science Corporation · Class III
- HeartStart Adult/Child Plus Pads — Philips Medical Systems Hsg · Class III
- Cardio Clear — CARDIO MEDICAL PRODUCTS, INC. · Class II
- Heartsync by Vermed — GRAPHIC CONTROLS ACQUISITION CORP · Class III
- Intellisense Adult Defibrillation Pads, CPR Device, Powerheart® G5 — Cardiac Science Corporation · Class III
- Intellisense Adult Defibrillation Pads, Powerheart® G5 — 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 — 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 26561df8-dbf0-4fe6-8543-781357a39ac5 37 fields · synced Jun 8, 2026