Identity
- Trade Name
- ECG Trunk Cable AAMI/IEC EUDAMEDECG Electrodes FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Reusable Leadsets/ECG leads/SPO2 Cables EUDAMEDECG Trunk Cable. AAMI/IEC. Connects MX4x Series 3-,5- and 6-wire lead sets to 12-pin ECG socket instruments (used on Bedside Monitors). Trunk Cable Length = 2.7 m (9 ft). Reusable. 1 Sales unit= 1 cable. FDA UDI
- Model / Reference
- 989803172221 EUDAMEDECG Trunk Cable AAMI/IEC FDA UDI
- Description
- ECG Trunk Cable. AAMI/IEC. Connects MX4x Series 3-,5- and 6-wire lead sets to 12-pin ECG socket instruments (used on Bedside Monitors). Trunk Cable Length = 2.7 m (9 ft). Reusable. 1 Sales unit= 1 cable. FDA UDI
Identifiers
- Catalog Number
- 989803172221 FDA UDI
- Primary DI / UDI-DI
- 00884838013544 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM332SN EUDAMED
- FDA Product Code
- DSI FDA UDI
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 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
No
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 Unsafe FDA UDI
ECG Trunk Cable AAMI/IEC 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 | 0884838BM332SN | 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 29169a72-fc7d-4a6c-88db-646084c6613a 61 fields · synced Jul 17, 2026
- FDA UDI 05faad43-60eb-4444-b8d6-3e5d65bf9d3e 36 fields · synced May 30, 2026