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Heartstart Adult Smart Pads Cartridge
EUDAMEDFDA UDIClass I (EU MDR)
Ref M5071A
Identity
- Trade Name
- Heartstart Adult Smart Pads Cartridge EUDAMEDPHILIPS HeartStart Adult SMART Pads FDA UDI
- Generic Name
- External defibrillation electrode, adult, single-use FDA UDI
- Device Name
- ALS and BLS Defib Pads and Electrodes EUDAMEDHeartStart Adult SMART Pads Cartridge FDA UDI
- Model / Reference
- M5071A EUDAMEDHeartstart Adult Smart Pads Cartridge FDA UDI
- Description
- HeartStart Adult SMART Pads Cartridge FDA UDI
Identifiers
- Catalog Number
- M5071A FDA UDI
- Primary DI / UDI-DI
- 00884838023741 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM480T6 EUDAMED
- FDA Product Code
- NSA 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
No
FDA UDI
Over-the-Counter
Yes
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 Adult Smart Pads Cartridge 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 8826e73b-f0b5-4bee-a9ad-4277d020b410 61 fields · synced Jul 29, 2026
- FDA UDI 6767d524-d2d7-4a7f-8493-16f27d7aabd0 35 fields · synced May 30, 2026