Identity
- Trade Name
- Gas exhaust lines EUDAMEDNA FDA UDI
- Generic Name
- Anaesthesia breathing circuit, single-use FDA UDI
- Device Name
- Gas exhaust lines EUDAMEDGas exhaust line, white conical and Colder, disposable, 0.18 m/7 in EUDAMEDFDA UDI
- Model / Reference
- 5514183 EUDAMED5514183 Gas exhaust line, white conical FDA UDI
- Description
- Gas exhaust line, white conical and Colder, disposable, 0.18 m/7 in FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278022639 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00381HM EUDAMEDB-00195278022639 EUDAMED
- FDA Product Code
- CAI FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- Anaesthesia breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5240 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
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
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: General-purpose multi-parameter bedside monitor
Gas exhaust lines by GE Healthcare Finland Oy — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8406821BUG00381HM | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00381HM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (3)
- EUDAMED 3a34333a-199c-4800-9264-ad61a94a21f9 61 fields · synced Oct 6, 2026
- EUDAMED 4a6c45be-7383-4723-83a2-76d9bba3db74 61 fields · synced May 18, 2026
- FDA UDI b8b0f392-8a93-46c8-86b3-204b5d043c81 33 fields · synced May 30, 2026