Vital Signs™ cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft
by AirLife Finland Oy Finland EUDAMEDGUDID
Ref 9446-910Model Vital Signs™ Cardiac output injectate probe
Product code DQEEMDN Z12050580
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number088948320041CardiacOutpUE | Date21 Oct 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10889483591437 | Date2 Apr 2025 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Vital Signs™ cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft EUDAMEDVital Signs™ GUDID
- Generic Name
- Injectate temperature probe
- Model / Ref / Catalog
- Vital Signs™ Cardiac output injectate probe, 9446-910
- Primary DI / UDI-DI
- 10889483591437
- Basic UDI-DI
- 088948320041CardiacOutpUE
- Direct Marketing DI
- 10889483591437
- FDA Product Code
- DQE
- EMDN Code
- Z12050580 Cardiac output measurement instruments - hardware accessories
- GMDN Term
- Injectate temperature probe
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 870.1230
- Market of Registration
- Finland
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- FI-MF-000001482
Other devices from AirLife Finland Oy
Properties & raw data
Show properties, registry sources and raw records
Other properties (21)
- 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: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
Sources (2)
- EUDAMED 2e96cd4a-64c9-4497-9e43-f4eabcd44dd8
- FDA UDI 71417245-dde1-4947-b159-85a68c506564