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Patient Breathing Circuit for iVent™ 201– 1.8 m/6 ft. Disposable
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref M1181639
Identity
- Trade Name
- Patient Breathing Circuit for iVent™ 201– 1.8 m/6 ft. Disposable EUDAMEDN/A FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- Breathing Circuits, w/o Water Trap EUDAMEDPatient Breathing Circuit for iVent™ 201, 1.8 m/6 ft., Disposable FDA UDI
- Model / Reference
- M1181639 EUDAMEDFDA UDI
- Description
- Patient Breathing Circuit for iVent™ 201, 1.8 m/6 ft., Disposable FDA UDI
Identifiers
- Catalog Number
- M1181639 FDA UDI
- Primary DI / UDI-DI
- 10190752148635 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10190752148635 EUDAMED
- FDA Product Code
- CAI FDA UDI
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
- GMDN Term
- Ventilator 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Patient Breathing Circuit for iVent™ 201– 1.8 m/6 ft. Disposable by AirLife Finland Oy — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10190752148635 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- AirLife Finland Oy
- EUDAMED SRN
- FI-MF-000001482
Sources (2)
- EUDAMED cc03debe-9479-42ae-93bf-7b821fac34c8 61 fields · synced Oct 5, 2026
- FDA UDI 324f7822-28f5-4a10-9a50-d70f34e97e1f 35 fields · synced May 30, 2026