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Vital Signs™ cardiac output injectate bath probe for GE monitors, 1.8 m/6 ft
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9446-909Model Vital Signs™ Cardiac output injectate probe
Identity
- Trade Name
- Vital Signs™ cardiac output injectate bath probe for GE monitors, 1.8 m/6 ft EUDAMEDVital Signs™ FDA UDI
- Generic Name
- Injectate temperature probe FDA UDI
- Device Name
- Vital Signs™ cardiac output injectate bath probe for GE monitors, 1.8 m/6 ft FDA UDI
- Model / Reference
- Vital Signs™ Cardiac output injectate probe EUDAMED9446-909 EUDAMEDFDA UDI
- Description
- Vital Signs™ cardiac output injectate bath probe for GE monitors, 1.8 m/6 ft FDA UDI
Identifiers
- Catalog Number
- 9446-909 FDA UDI
- Primary DI / UDI-DI
- 10889483591420 EUDAMEDFDA UDI
- Basic UDI-DI
- 088948320041CardiacOutpUE EUDAMED
- Direct Marketing DI
- 10889483591420 EUDAMED
- 510(k) Number
- K915073 FDA UDI
- 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
Vital Signs™ cardiac output injectate bath probe for GE monitors, 1.8 m/6 ft 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 | 088948320041CardiacOutpUE | 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 b81b9e07-3071-49e0-9cae-fb4c1278a085 61 fields · synced Oct 6, 2026
- FDA UDI f744c2a1-b18c-44e1-bd4f-5dedbb1b7bd4 37 fields · synced May 30, 2026