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Intellisense™ Pediatric Defibrillation Pads Powerheart® G5
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- Intellisense™ Pediatric Defibrillation Pads Powerheart® G5 FDA UDI
- Generic Name
- External defibrillation electrode, paediatric, single-use FDA UDI
- Device Name
- Intellisense Pediatric Defibrillation Pads, reduced energy, for Powerheart G5 (up to 8 years of age or 55 lbs) FDA UDI
- Model / Reference
- XELAED003B FDA UDI
- Description
- Intellisense Pediatric Defibrillation Pads, reduced energy, for Powerheart G5 (up to 8 years of age or 55 lbs) FDA UDI
Identifiers
- Catalog Number
- XELAED003B FDA UDI
- Primary DI / UDI-DI
- 00812394020515 FDA UDI
- 510(k) Number
- K122758 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- External defibrillation electrode, paediatric, 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, paediatric, single-use
Intellisense™ Pediatric Defibrillation Pads Powerheart® G5 by Cardiac Science Corporation — Class III — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as External defibrillation electrode, paediatric, single-use.
- DDU-1XXX/2XXX Series Pediatric Pads Configuration — DEFIBTECH, L.L.C. · Class III
- HeartStart Pads — Philips Medical Systems Hsg · Class III
- MedSource Electrodes — MEDSOURCE INTERNATIONAL LLC · Class II
- Powerheart® Pediatric Pads — Zoll Medical Corporation · Class III
- Replacement Infant/Child AED Reduced Energy Electrodes — PHYSIO-CONTROL, Inc. · Class III
- Cardio Clear — CARDIO MEDICAL PRODUCTS, INC. · Class II
- Intellisense™ Pediatric Defibrillation Pads Powerheart® G5 — Zoll Medical Corporation · Class III
- EDGE SYSTEM — PHYSIO-CONTROL, Inc. · Class III
Cleared under the same submission
K122758 also covers:
- AED Manager, V.2.0.5.0 Powerheart G5 — Cardiac Science Corporation
- Intellisense Adult Defibrillation Pads, Powerheart® G5 — Cardiac Science Corporation
- Intellisense Adult Defibrillation Pads, Powerheart® G5 — Cardiac Science Corporation
- Intellisense® Battery Powerheart® G5 — Cardiac Science Corporation
- Intellisense™ Pediatric Defibrillation Pads Powerheart® G5 — Cardiac Science Corporation
- Powerheart G5 Kit, Semi, US Eng/ESP LA — Cardiac Science Corporation
- Powerheart® G5 Automatic AED — Cardiac Science Corporation
- Powerheart® G5 Automatic AED — Cardiac Science Corporation
- Powerheart® G5 Semi Automatic AED — Cardiac Science Corporation
- AED Manager, V.2.1.1.0 Powerheart G5 — Zoll Medical Corporation
- Intellisense Adult Defibrillation Pads, Powerheart® G5 — Zoll Medical Corporation
- Intellisense Adult Defibrillation Pads, Powerheart® G5 — 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
- Cardiac Science Corporation
Sources (1)
- FDA UDI e4e7b94a-da05-4c21-b8aa-655a3e338709 37 fields · synced Jun 1, 2026