Identity
- Trade Name
- Medium Switched Int Pdls EUDAMEDHeartStart FDA UDI
- Generic Name
- Internal defibrillation electrode, adult, reusable FDA UDI
- Device Name
- Internal Paddles & Internal Paddle Accs. EUDAMEDMedium Switched Int Pdls FDA UDI
- Model / Reference
- M4743A EUDAMEDMedium Switched Int Pdls FDA UDI
- Description
- Medium Switched Int Pdls FDA UDI
Identifiers
- Catalog Number
- M4743A FDA UDI
- Primary DI / UDI-DI
- 00884838094741 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838094741 EUDAMED
- FDA Product Code
- LDD FDA UDIMKJ FDA UDI
- EMDN Code
- Z12030580 DEFIBRILLATORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Internal defibrillation electrode, adult, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5300 FDA UDI870.5310 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Medium Switched Int Pdls 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-00884838094741 | 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-000002321
- Authorised Representative
- Philips Medizin Systeme Böblingen GmbH DE-AR-000006030
Sources (2)
- EUDAMED d580b6ff-27b6-4c6a-a84a-e9ffc8b08f3a 61 fields · synced Jul 9, 2026
- FDA UDI c3e70b9c-1467-429b-97ec-da7fbba8b1ac 37 fields · synced May 26, 2026