Guedel airway, 30mm, Clear
by Besmed Health Business Corp. 7 variants
Ref AW-61150Model AW-61130
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number4716770AW06100ER 04716770611501 | Date15 Nov 2021 | StatusActive |
| United States | GUDID listing GUDID | Number04716770611501 | Date18 Oct 2017 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Disposable Guedel AIRWAY,50MM
- Generic Name
- Oropharyngeal airway, single-use
- Device Name
- Guedel airway, 30mm, Clear
- Model / Reference
- AW-61130, AW-61150
- Primary DI / UDI-DI
- 04716770611501
- Basic UDI-DI
- 4716770AW06100ER
- FDA Product Code
- CAE
- EMDN Code
- R010102 Guedel airway tubes
- GMDN Term
- Oropharyngeal airway, single-use
- Device Class
- Class I
- Regulation Number
- 868.5110
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- TW-MF-000007246
- Authorised representative
- mdi Europa GmbH DE-AR-000006218
Other devices from Besmed Health Business Corp.
Properties
Other properties (17)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No