Identity
- Trade Name
- HeartStart Pediatric Pads FR2 EUDAMEDPHILIPS FR2/FR2+ Infant/Child Defibrillation Pads FDA UDI
- Generic Name
- External defibrillation electrode, paediatric, single-use FDA UDI
- Device Name
- ALS and BLS Defib Pads and Electrodes EUDAMEDFR2 Infant/Child Reduced Energy Pads FDA UDI
- Model / Reference
- M3870A EUDAMEDHeartStart Pediatric Pads FR2 FDA UDI
- Description
- FR2 Infant/Child Reduced Energy Pads FDA UDI
Identifiers
- Catalog Number
- M3870A FDA UDI
- Primary DI / UDI-DI
- 00884838023734 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838023734 EUDAMED
- FDA Product Code
- MLN FDA UDIMKJ FDA UDI
- EMDN Code
- Z12030585 DEFIBRILLATORS - CONSUMABLES EUDAMED
- GMDN Term
- External defibrillation electrode, paediatric, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2360 FDA UDI870.5310 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
HeartStart Pediatric Pads FR2 by Philips Medical Systems — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838023734 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002128
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 96ec1522-cfe0-4f4e-ab15-33683d7e1e98 61 fields · synced Jun 17, 2026
- FDA UDI b084e666-9862-4ec6-ac34-3b717891fc9e 35 fields · synced May 30, 2026