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PW CBL Long Complete Lead Set IEC
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989803151661
Identity
- Trade Name
- PW CBL Long Complete Lead Set IEC EUDAMEDNOUN FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- TC 10, TC20, TC30, TC50, TC70 lead sets EUDAMEDLong complete lead set for PageWriter TC Series Cardiographs, IEC color coded. Consisting of 2 long arm leads (54" (1,37m)), 2 long leg leads (56" (1,42m)), 2 long 1 into 3 Trident leads ( 42"(1,07m)), 2 lead separators, 2.54 DIA, 10 banana post adapters, 2 Trident Yoke labels (C1-C3, C4-C6), 4 colored clips, 14x colored rings, 6 white base rings and instructions for use. This lead set comes fully assembled. 1 complete lead set = 1 sales unit FDA UDI
- Model / Reference
- 989803151661 EUDAMEDPW CBL Long Complete Lead Set IEC FDA UDI
- Description
- Long complete lead set for PageWriter TC Series Cardiographs, IEC color coded. Consisting of 2 long arm leads (54" (1,37m)), 2 long leg leads (56" (1,42m)), 2 long 1 into 3 Trident leads ( 42"(1,07m)), 2 lead separators, 2.54 DIA, 10 banana post adapters, 2 Trident Yoke labels (C1-C3, C4-C6), 4 colored clips, 14x colored rings, 6 white base rings and instructions for use. This lead set comes fully assembled. 1 complete lead set = 1 sales unit FDA UDI
Identifiers
- Catalog Number
- 989803151661 FDA UDI
- Primary DI / UDI-DI
- 00884838014985 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
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
Yes
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
Category: Electrocardiographic lead set, reusable
PW CBL Long Complete Lead Set 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
European Union Active
CE/MDR
United States Pending data
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 a13e67f7-f7e1-4a4d-b7cd-2d91af3a9839 61 fields · synced Jun 18, 2026
- FDA UDI 182b43ab-4281-4cde-a870-f7b09f0dee17 36 fields · synced May 24, 2026