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Patient Circuit, 15mm x 1.8m
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 006712Model Patient circuits (Non-heated)Model Patient circuits
Identity
- Trade Name
- Patient Circuit, 15mm x 1.8m EUDAMEDVivo 1/2, Vivo 3 FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Device Name
- Patient circuits (Non-heated) EUDAMEDCircuit: Single Limb 15mm x 1.8m Disposable EUDAMEDCircuit: Single limb 15 mm. Single patient multiple use FDA UDI
- Model / Reference
- Patient circuits (Non-heated) EUDAMED006712 EUDAMEDFDA UDIPatient circuits EUDAMED
- Description
- Circuit: Single limb 15 mm. Single patient multiple use FDA UDI
Identifiers
- Catalog Number
- 006712 FDA UDI
- Primary DI / UDI-DI
- 07321820067121 EUDAMEDFDA UDI
- Basic UDI-DI
- 7321820109998U EUDAMEDB-07321820067121 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
Patient Circuit, 15mm x 1.8m by Breas Medical AB — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 7321820109998U | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7321820109998U | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (3)
- EUDAMED b2565cb2-a14d-4974-82a4-17a09d8307f1 61 fields · synced Jul 28, 2026
- EUDAMED fe1c3925-029c-49cd-aa10-d013becbb833 61 fields · synced May 19, 2026
- FDA UDI b2bb2869-7358-4974-9836-10bf7558ca37 34 fields · synced May 30, 2026