Identity
- Trade Name
- HeartStart Pads FDA UDI
- Generic Name
- External defibrillation electrode, paediatric, single-use FDA UDI
- Device Name
- HS Pedi Radiotransparent Pads FDA UDI
- Model / Reference
- 989803125411 FDA UDI
- Description
- HS Pedi Radiotransparent Pads FDA UDI
Identifiers
- Catalog Number
- M3719A FDA UDI
- Primary DI / UDI-DI
- 00884838002883 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
No
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
No
FDA UDI
Category: External defibrillation electrode, paediatric, single-use
HeartStart Pads by Philips Medical Systems Hsg — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as External defibrillation electrode, paediatric, single-use.
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- Intellisense™ Pediatric Defibrillation Pads Powerheart® G5 — Cardiac Science Corporation · Class III
- MedSource Electrodes — MEDSOURCE INTERNATIONAL LLC · Class II
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- Cardio Clear — CARDIO MEDICAL PRODUCTS, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems Hsg
Sources (2)
- FDA UDI 1d1186d2-9a84-4d37-af6e-86ae510de97d 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026