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Vital Signs™ Invasive Blood Pressure Cable For Use with Edwards Lifesciences Tr…
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2021197-003Model Invasive Blood Pressure Cables
Identity
- Trade Name
- Vital Signs™ Invasive Blood Pressure Cable For Use with Edwards Lifesciences TruWave, Dual, 3.6 m/12 ft. EUDAMEDVital Signs™ FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Vital Signs™ Invasive Blood Pressure Cable For Use with Edwards Lifesciences TruWave, Dual, 3.6 m/12 ft. FDA UDI
- Model / Reference
- Invasive Blood Pressure Cables EUDAMED2021197-003 EUDAMEDFDA UDI
- Description
- Vital Signs™ Invasive Blood Pressure Cable For Use with Edwards Lifesciences TruWave, Dual, 3.6 m/12 ft. FDA UDI
Identifiers
- Catalog Number
- 2021197-003 FDA UDI
- Primary DI / UDI-DI
- 10889483576274 EUDAMEDFDA UDI
- Basic UDI-DI
- 088948320041aIBPCables2U EUDAMED
- Direct Marketing DI
- 10889483576274 EUDAMED
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z129080 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - 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
- 870.1025 FDA UDI
- Market of Registration
- Finland 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
Yes
FDA UDI
Vital Signs™ Invasive Blood Pressure Cable For Use with Edwards Lifesciences Tr… by AirLife Finland Oy — 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 | 088948320041aIBPCables2U | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AirLife Finland Oy
- EUDAMED SRN
- FI-MF-000001482
Sources (2)
- EUDAMED 9bd7556a-e251-49a5-b69d-97fa956231c9 61 fields · synced Jun 18, 2026
- FDA UDI b62adb89-7aaa-4a55-a41a-4b5ed335c25f 36 fields · synced May 30, 2026