Identity
- Trade Name
- Short Neonatal ECG 2.0 Cable AAMI EUDAMEDMR Patient Care Short Neonatal ECG 2.0 Cable AAMI FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Reusable Electrocardiographic Leads EUDAMEDCAB,4 LD,NEO.MRI ECG,3160 FDA UDI
- Model / Reference
- 9222 EUDAMEDShort Neonatal ECG 2.0 Cable AAMI FDA UDI
- Description
- CAB,4 LD,NEO.MRI ECG,3160 FDA UDI
Identifiers
- Catalog Number
- 9222 FDA UDI
- Primary DI / UDI-DI
- 00884838102347 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM455T7 EUDAMED
- Direct Marketing DI
- 00884838102347 EUDAMED
- FDA Product Code
- MWI FDA UDIDSA 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 UDI870.2900 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
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
Short Neonatal ECG 2.0 Cable AAMI 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 | 0884838BM455T7 | 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 8a30ba80-0cec-477f-995a-66214766d082 61 fields · synced Oct 6, 2026
- FDA UDI 4ed4ae5f-18e8-440e-9b88-03484de57c74 37 fields · synced May 25, 2026