Identity
- Trade Name
- Neonatal ECG 3.0 Cable AAMI EUDAMEDMR Patient Care Neonatal ECG 3.0 Cable AAMI FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Reusable Electrocardiographic Leads EUDAMEDECG lead cable designed for use with 3rd-generation wireless ECG module and Neonatal Quadtrodes (AAMI coded leads.) FDA UDI
- Model / Reference
- 989803193741 EUDAMEDNeonatal ECG 3.0 Cable AAMI FDA UDI
- Description
- ECG lead cable designed for use with 3rd-generation wireless ECG module and Neonatal Quadtrodes (AAMI coded leads.) FDA UDI
Identifiers
- Catalog Number
- 989803193741 FDA UDI
- Primary DI / UDI-DI
- 00884838121140 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1072M2 EUDAMED
- Direct Marketing DI
- 00884838121140 EUDAMED
- FDA Product Code
- MWI FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Neonatal ECG 3.0 Cable AAMI by Philips Medizin Systeme Böblingen GmbH — 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 | 0884838BM1072M2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED 8df588fd-6337-4bf9-b0a4-461756510af9 61 fields · synced Jul 11, 2026
- FDA UDI 1f1caa19-25d0-4944-9a5b-f9b2e28be965 35 fields · synced May 24, 2026