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Invasive Blood Pressure Trunk Cables
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2104162-002Model 2103966-001
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Invasive Blood Pressure Trunk Cables EUDAMEDIBP CABLE, EDWARDS LS TRUWAVE, SINGLE, 1.2 M/4 FT. FDA UDI
- Model / Reference
- 2103966-001 EUDAMED2104162-002 EUDAMEDInvasive Blood Pressure Cable, Edwards LS TruWave, Single, 1.2 m/4 ft. FDA UDI
- Description
- IBP CABLE, EDWARDS LS TRUWAVE, SINGLE, 1.2 M/4 FT. FDA UDI
Identifiers
- Catalog Number
- 2104162-002 FDA UDI
- Primary DI / UDI-DI
- 00840682136549 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00043GW EUDAMED
- FDA Product Code
- IKD FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Market of Registration
- Finland 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Invasive Blood Pressure Trunk Cables by GE Healthcare Finland Oy — 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 | 8406821BUG00043GW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (2)
- EUDAMED b49273ea-8ca3-4e31-902a-87bbbfad16d6 61 fields · synced Oct 6, 2026
- FDA UDI 024f7f21-dc93-4b8b-bb88-682b5c6ba1f0 35 fields · synced May 30, 2026