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Vital Signs™ Flexible Tube, Disposable
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 557033300
Identity
- Trade Name
- Vital Signs™ Flexible Tube, Disposable EUDAMEDVital Signs™ FDA UDI
- Generic Name
- Breathing circuit catheter mount, single-use FDA UDI
- Device Name
- Vital Signs™ Fixed Catheter Mounts EUDAMEDVital Signs™ Flexible Tube, Disposable FDA UDI
- Model / Reference
- 557033300 EUDAMEDFDA UDI
- Description
- Vital Signs™ Flexible Tube, Disposable FDA UDI
Identifiers
- Catalog Number
- 557033300 FDA UDI
- Primary DI / UDI-DI
- 10889483586570 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10889483586570 EUDAMED
- FDA Product Code
- BYX FDA UDI
- EMDN Code
- R020201 FIXED CATHETER MOUNTS EUDAMED
- GMDN Term
- Breathing circuit catheter mount, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5860 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
Vital Signs™ Flexible Tube, Disposable by AirLife Finland Oy — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-10889483586570 | 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 bf514704-5e0e-44e5-a3c4-006451640075 61 fields · synced Oct 11, 2026
- FDA UDI 1f191f38-ccb0-4c18-9ef0-db67315d3387 35 fields · synced May 29, 2026