CuffGuard
by Idmed France EUDAMEDGUDID
Ref CG-TUB1Model CG-Tube
Product code BSKEMDN Z1203019099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number03665023001112 | Date19 Dec 2025 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number3665023CG-TubeRE | Date7 Nov 2025 | StatusActive |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Endotracheal tube cuff inflator
- Device Name
- Connecting tube
- Model / Reference
- CG-Tube, CG-TUB1
- Primary DI / UDI-DI
- 03665023001112
- Basic UDI-DI
- 3665023CG-TubeRE
- Unit of Use DI
- 03665023001068
- 510(k) Number
- FDA Product Code
- BSK
- EMDN Code
- Z1203019099 Various instruments for anaesthesia and pulmonary ventilation support – other
- GMDN Term
- Endotracheal tube cuff inflator
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 868.5750
- Market of Registration
- France
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- FR-MF-000002402
Other devices from Idmed
Properties & raw data
Show properties, registry sources and raw records
Other properties (19)
- Sterile: 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
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No
Sources (2)
- EUDAMED ab992493-e043-4b76-9563-0fe129c25477
- FDA UDI 21ff9b7c-07d7-493d-ac70-d18ed0c46713