Identity
- Trade Name
- Heartstart Pads EUDAMEDHeartStart Adult/Child Plus Pads FDA UDIHeartStart FDA UDI
- Generic Name
- External defibrillation electrode, adult, single-use FDA UDI
- Device Name
- ALS and BLS Defib Pads and Electrodes EUDAMEDAdult/Child Plus Multifunction Electrode Pads FDA UDIAdult/Child Radiolucent Multifunction Electrode Pads FDA UDI
- Model / Reference
- M3716A EUDAMEDM3713A EUDAMEDHeartstart Pads FDA UDI
- Description
- Adult/Child Plus Multifunction Electrode Pads FDA UDIAdult/Child Radiolucent Multifunction Electrode Pads FDA UDI
Identifiers
- Catalog Number
- M3713A FDA UDIM3716A FDA UDI
- Primary DI / UDI-DI
- 00884838111486 EUDAMEDFDA UDI10884838002842 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM480T6 EUDAMED
- Unit of Use DI
- 00884838111493 EUDAMED00884838111325 EUDAMED
- FDA Product Code
- MKJ FDA UDI
- EMDN Code
- Z12030585 DEFIBRILLATORS - CONSUMABLES EUDAMED
- GMDN Term
- External defibrillation electrode, adult, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Regulation Number
- 870.5310 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 Pads by Philips Medical Systems — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM480T6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (4)
- EUDAMED e717506f-79cd-41cb-89fa-4b101b5dd416 61 fields · synced Jul 27, 2026
- FDA UDI 338e1766-0f40-4648-8a6c-2573dc164a13 35 fields · synced May 30, 2026
- FDA UDI ca5c6bd8-9da0-43b9-9be8-407abbbc941f 35 fields · synced May 30, 2026
- EUDAMED ce29374b-f901-483f-89ec-c08f52cd2d75 61 fields · synced Jul 27, 2026