Identity
- Trade Name
- DAR FDA UDI
- Generic Name
- Breathing circuit catheter mount, single-use FDA UDI
- Device Name
- Catheter Mount CO2 Sampling Port FDA UDI
- Model / Reference
- 330/5646 FDA UDI
- Description
- Catheter Mount CO2 Sampling Port FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20884522028230 FDA UDI
- FDA Product Code
- BZA FDA UDI
- GMDN Term
- Breathing circuit catheter mount, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breathing circuit catheter mount, single-use.
- AirLife™ — VYAIRE MEDICAL, INC. · Class I
- GIBECK — TELEFLEX INCORPORATED · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Portex — ICU MEDICAL, INC. · Class II
- Portex — ICU MEDICAL, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 1ad13de6-4e7e-4dab-8ea8-0fba6d18d921 36 fields · synced May 30, 2026