Identity
- Trade Name
- Neonatal ECG Electrodes (25) EUDAMEDMR Patient Care Neonatal ECG Electrodes (25) FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- Single use Electrocardiographic Electro EUDAMEDELECTRODE, NEONATE MRI ECG, QUADTRODE CV, 25/BOX FDA UDI
- Model / Reference
- 989803179051 EUDAMEDNeonatal ECG Electrodes (25) FDA UDI
- Description
- ELECTRODE, NEONATE MRI ECG, QUADTRODE CV, 25/BOX FDA UDI
Identifiers
- Catalog Number
- 989803179051 FDA UDI
- Primary DI / UDI-DI
- 10884838101941 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM454T5 EUDAMED
- Unit of Use DI
- 00884838101944 EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER 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
- Not 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 77.700 Millimeter FDA UDIWidth — 77.700 Millimeter FDA UDI
Neonatal ECG Electrodes (25) by Invivo, a division of Philips Medical Systems — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0884838BM454T5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Invivo, a division of Philips Medical Systems
- EUDAMED SRN
- US-MF-000002177
- Authorised Representative
- Philips Medizin Systeme Böblingen GmbH DE-AR-000006030
Sources (2)
- EUDAMED 33f4426e-178a-4719-81e8-cd0c39f49347 61 fields · synced Oct 6, 2026
- FDA UDI b12336bf-159f-4b18-9851-b349e2720c1e 38 fields · synced May 30, 2026