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Preattached Leadwire Electrode, Medium
EUDAMEDFDA UDIClass I (EU MDR)
Ref 13952D
Identity
- Trade Name
- PREATTACHED LEADWIRE ELECTRODE, MEDIUM EUDAMEDECG Cables and Leadsets FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- Electrocardiographic Electrodes Cardinal EUDAMEDPreattached Leadwire Electrode, Medium Metallic copper IEC color 45cm/18" leadwires with 1.5mm/.060" safety socket rectangular 33cm x 22cm cloth backingwith Ag/AgCl sensor, 3/pouch, 300/case. FDA UDI
- Model / Reference
- 13952D EUDAMEDPREATTACHED LEADWIRE ELECTRODE, MEDIUM FDA UDI
- Description
- Preattached Leadwire Electrode, Medium Metallic copper IEC color 45cm/18" leadwires with 1.5mm/.060" safety socket rectangular 33cm x 22cm cloth backingwith Ag/AgCl sensor, 3/pouch, 300/case. FDA UDI
Identifiers
- Catalog Number
- 13952D FDA UDI
- Primary DI / UDI-DI
- 20884838000883 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM532SY EUDAMED
- Unit of Use DI
- 10884838000886 EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- Electrocardiographic electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2360 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
Preattached Leadwire Electrode, Medium 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 | 0884838BM532SY | 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-000002321
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED edbcf323-b8d7-4485-8baa-cd873fadc74a 61 fields · synced Jul 22, 2026
- FDA UDI 8b77b1de-85a5-4152-8f8c-b98bef545647 35 fields · synced May 30, 2026