Identity
- Trade Name
- Powerheart®Pediatric Pads FDA UDI
- Generic Name
- External defibrillation electrode, paediatric, single-use FDA UDI
- Device Name
- Pediatric defibrillation pads with two-year shelf life under GE part number FDA UDI
- Model / Reference
- 2019199-003 FDA UDI
- Description
- Pediatric defibrillation pads with two-year shelf life under GE part number FDA UDI
Identifiers
- Catalog Number
- 2019199-003 FDA UDI
- Primary DI / UDI-DI
- 00812394020607 FDA UDI
- 510(k) Number
- K022929 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
Powerheart®Pediatric Pads by Cardiac Science Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
K022929 also covers:
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 575e7949-d48e-4919-afa0-1dba1fa36f23 37 fields · synced Jun 6, 2026