Heated Patient Circuit Type 2
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Heated Patient Circuit Type 2 EUDAMEDVivo 1/2, Vivo 3 FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Device Name
- Heated Wire Patient Circuit EUDAMEDFDA UDIHeated Patient Circuits EUDAMED
- Model / Reference
- Heated Patient Circuits EUDAMED006990 EUDAMEDFDA UDI
- Description
- Heated Wire Patient Circuit FDA UDI
Identifiers
- Catalog Number
- 006990 FDA UDI
- Primary DI / UDI-DI
- 07321820069903 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07321820069903 EUDAMED7321820149999Q EUDAMED
- FDA Product Code
- MNS FDA UDIMNT FDA UDI
- EMDN Code
- R020107 THERMOREGULATED BREATHING CIRCUITS EUDAMED
- GMDN Term
- Ventilator breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Sweden 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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Ventilator breathing circuit, single-use
Heated Patient Circuit Type 2 by Breas Medical AB — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ventilator breathing circuit, single-use.
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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 | B-07321820069903 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-07321820069903 | 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 6c8e3d7b-c8de-4d48-8ec3-189c24d04962 61 fields · synced Jul 9, 2026
- EUDAMED 627a59c9-7d3c-4c3f-890d-69bc22f09fe2 61 fields · synced May 17, 2026
- FDA UDI 09c60309-169e-4126-bf25-904def23e362 36 fields · synced May 30, 2026