← Back to catalogue
Single Patient Breathing Hose
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 004465Model Patient circuitsModel Patient circuits (Non-heated)
Identity
- Trade Name
- Single Patient Breathing Hose EUDAMEDVivo 1/2, Vivo 3 FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Device Name
- Single Patient Breathing Hose EUDAMEDPatient circuits (Non-heated) EUDAMEDCircuit: Single limb, 22 mm. Single, patient multiple use FDA UDI
- Model / Reference
- Patient circuits EUDAMED004465 EUDAMEDFDA UDIPatient circuits (Non-heated) EUDAMED
- Description
- Circuit: Single limb, 22 mm. Single, patient multiple use FDA UDI
Identifiers
- Catalog Number
- 004465 FDA UDI
- Primary DI / UDI-DI
- 07321820044658 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07321820044658 EUDAMED7321820109998U EUDAMED
- FDA Product Code
- CAI FDA UDI
- EMDN Code
- R02010199 STANDARD BREATHING CIRCUITS - OTHER EUDAMED
- GMDN Term
- Ventilator breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5240 FDA UDI
- Market of Registration
- Sweden 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Single Patient Breathing Hose by Breas Medical AB — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07321820044658 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07321820044658 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (3)
- EUDAMED ee8e4ecb-04a6-4ab7-ae48-d5c620ecbd56 61 fields · synced Oct 6, 2026
- EUDAMED c5363499-772d-4744-9011-a300c85761e7 61 fields · synced May 19, 2026
- FDA UDI 9909e8a6-2b95-4c34-b752-18c2e88c1580 34 fields · synced May 30, 2026