← Back to catalogue
Vital Signs™ Cardiac output in-line injectate probe for GE monitors, Edwards CO…
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9446-910Model Vital Signs™ Cardiac output injectate probe
Identity
- Trade Name
- Vital Signs™ Cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft EUDAMEDVital Signs™ FDA UDI
- Generic Name
- Injectate temperature probe FDA UDI
- Device Name
- Cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft FDA UDI
- Model / Reference
- Vital Signs™ Cardiac output injectate probe EUDAMED9446-910 EUDAMEDFDA UDI
- Description
- Cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft FDA UDI
Identifiers
- Catalog Number
- 9446-910 FDA UDI
- Primary DI / UDI-DI
- 10190752181373 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190752TDHEL1211UJ EUDAMED
- Direct Marketing DI
- 10190752181373 EUDAMED
- FDA Product Code
- DQE FDA UDI
- EMDN Code
- Z12050580 CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Injectate temperature probe FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1230 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
MR Unsafe FDA UDI
Vital Signs™ Cardiac output in-line injectate probe for GE monitors, Edwards CO… 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 | 0190752TDHEL1211UJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AirLife Finland Oy
- EUDAMED SRN
- FI-MF-000001482
Sources (2)
- EUDAMED 8e3de114-48c5-4159-ab85-a9fadbcbf5f3 61 fields · synced Oct 6, 2026
- FDA UDI c1921029-4d3b-4249-9bf1-52d5f67bf273 36 fields · synced May 30, 2026