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CBL OR 5-Lead ECG Trunk Cable, AAMI/IEC
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989803170181
Identity
- Trade Name
- CBL OR 5-Lead ECG Trunk Cable, AAMI/IEC EUDAMEDECG Trunk Cable FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- ECG Trunk Cables EUDAMEDOR 5-Lead ECG Trunk Cable, AAMI/IEC. Trunk can be used for either color code system AAMI and IEC. 1 trunk cable per bag. Cable length = 2,7 m (9ft). Use with indicated 3-lead products FDA UDI
- Model / Reference
- 989803170181 EUDAMEDCBL OR 5-Lead ECG Trunk Cable, AAMI/IEC FDA UDI
- Description
- OR 5-Lead ECG Trunk Cable, AAMI/IEC. Trunk can be used for either color code system AAMI and IEC. 1 trunk cable per bag. Cable length = 2,7 m (9ft). Use with indicated 3-lead products FDA UDI
Identifiers
- Catalog Number
- 989803170181 FDA UDI
- Primary DI / UDI-DI
- 00884838012486 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM557TG EUDAMED
- FDA Product Code
- DPS 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
- 870.2340 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 Unsafe FDA UDI
CBL OR 5-Lead ECG Trunk Cable, AAMI/IEC by Philips Medizin Systeme Böblingen GmbH — 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 | 0884838BM557TG | 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 86b5060b-c129-43a5-9875-7ba01450c66e 61 fields · synced Oct 6, 2026
- FDA UDI e21f9974-cbc2-43f8-bc6e-6947fd69544e 36 fields · synced May 30, 2026