Identity
- Trade Name
- DAR FDA UDI
- Generic Name
- Breathing circuit catheter mount, single-use FDA UDI
- Device Name
- Catheter Mount EUDAMEDCatheter Mount Double Swivel Connector, Extendable Extension Tube FDA UDI
- Model / Reference
- 331U5661 EUDAMEDFDA UDI
- Description
- Catheter Mount Double Swivel Connector, Extendable Extension Tube FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521842526 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763000B000260788 EUDAMED
- FDA Product Code
- BZA FDA UDI
- EMDN Code
- R020202 MOBILE CATHETER MOUNTS EUDAMED
- GMDN Term
- Breathing circuit catheter mount, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5810 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Breathing circuit catheter mount, single-use
Dar by Covidien LP — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (2)
- FDA UDI aaa60191-1465-45eb-9cb8-18a4fa60b2b8 36 fields · synced Jun 18, 2026
- EUDAMED a94638d6-2eef-433e-8004-6f98cad4e842 61 fields · synced Jun 18, 2026