Identity
- Trade Name
- Smart Pads III EUDAMEDPHILIPS HeartStart SMARTPADS III FDA UDI
- Generic Name
- Multifunction cardiac treatment electrode FDA UDI
- Device Name
- ALS and BLS Defib Pads and Electrodes EUDAMEDSMART Pads III, 5 sets FDA UDI
- Model / Reference
- 989803149991 EUDAMEDSmart Pads III FDA UDI
- Description
- SMART Pads III, 5 sets FDA UDI
Identifiers
- Catalog Number
- 989803149991 FDA UDI
- Primary DI / UDI-DI
- 00884838023772 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM480T6 EUDAMED
- Unit of Use DI
- 00884838120495 EUDAMED
- FDA Product Code
- MKJ FDA UDI
- EMDN Code
- Z12030585 DEFIBRILLATORS - CONSUMABLES EUDAMED
- GMDN Term
- Multifunction cardiac treatment electrode 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
Smart Pads III 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 (2)
- EUDAMED 1bc433b1-7f1d-4d31-90ba-066e319845d3 61 fields · synced Jun 8, 2026
- FDA UDI a962229b-82d8-43e0-a84d-f487e12a65f3 35 fields · synced May 30, 2026