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Single Limb Insert
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 005521Model Patient circuits (Non-heated)Model Patient circuits
Identity
- Trade Name
- Single Limb Insert EUDAMEDVivo 65 FDA UDI
- Generic Name
- Mechanical expiratory valve, single-use FDA UDI
- Device Name
- Patient circuits (Non-heated) EUDAMEDSingle Limb Insert EUDAMEDFDA UDI
- Model / Reference
- Patient circuits (Non-heated) EUDAMED005521 EUDAMEDFDA UDIPatient circuits EUDAMED
- Description
- Single Limb Insert FDA UDI
Identifiers
- Catalog Number
- 005521 FDA UDI
- Primary DI / UDI-DI
- 07321820055210 EUDAMEDFDA UDI
- Basic UDI-DI
- 7321820109998U EUDAMEDB-07321820055210 EUDAMED
- 510(k) Number
- K160481 FDA UDI
- FDA Product Code
- CBK FDA UDINOU FDA UDI
- EMDN Code
- R02010199 STANDARD BREATHING CIRCUITS - OTHER EUDAMED
- GMDN Term
- Mechanical expiratory valve, single-use 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
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Single Limb Insert 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 1f119867-349a-48e5-8fc5-689268c6d4ef 61 fields · synced Oct 5, 2026
- EUDAMED a57949a5-ec3f-4ace-b5dd-579a7e5eb640 61 fields · synced May 19, 2026
- FDA UDI d36799d3-39e3-4129-8c12-a3eefc70f0a0 36 fields · synced May 30, 2026