Long Chest Lead Set (Both AAMI and IEC)
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Long Chest Lead Set (Both AAMI and IEC) EUDAMEDNOUN FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- TC 10, TC20, TC30, TC50, TC70 lead sets EUDAMEDLong Chest lead Set for PageWriter TC Series Cardiographs, AAMI and IEC color coded. Consisting of one long 1 in 3 (Trident) Lead (42" (1,07m)), 13*2 colored rings, 3 brown base rings, 3 white base rings (both AAMI and IEC), 3 banana post adapters, 1 lead separatorr 2.54 DIA, 4 Trident Yoke lead description lables (V1-V3, V4-V6, C1-C3, C4-C6) and instructions for use. The Trident lead comes assembled with the lead separator. FDA UDI
- Model / Reference
- 989803151691 EUDAMEDLong Chest Lead Set (Both AAMI and IEC) FDA UDI
- Description
- Long Chest lead Set for PageWriter TC Series Cardiographs, AAMI and IEC color coded. Consisting of one long 1 in 3 (Trident) Lead (42" (1,07m)), 13*2 colored rings, 3 brown base rings, 3 white base rings (both AAMI and IEC), 3 banana post adapters, 1 lead separatorr 2.54 DIA, 4 Trident Yoke lead description lables (V1-V3, V4-V6, C1-C3, C4-C6) and instructions for use. The Trident lead comes assembled with the lead separator. FDA UDI
Identifiers
- Catalog Number
- 989803151691 FDA UDI
- Primary DI / UDI-DI
- 00884838013001 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM511SQ EUDAMED
- FDA Product Code
- DSA FDA UDI
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Electrocardiographic lead set, reusable
Long Chest Lead Set (Both AAMI and IEC) by Philips Medical Systems — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM511SQ | 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 34a3f20d-d766-4bd3-a760-69e855df3394 61 fields · synced Jul 9, 2026
- FDA UDI f4724c55-2412-4cd0-9804-a3d3c63230df 36 fields · synced May 30, 2026