500434-100
by Benson Medical Instruments Co.
500434-100 is a Class II device made by Benson Medical Instruments Co., cleared under FDA 510(k) K123896 on 10 Sep 2013 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI B207500434100), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB207500434100 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123896 | Date10 Sep 2013 | StatusActive |
Official records
- FDA 510(k) database K123896
Across registries
- FDA 510(k) K123896 decided 10 Sep 2013 Active
- FDA GUDID UDI-DI B207500434100 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K123896
- Listed FDA GUDID B207500434100
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Breathing mouthpiece, single-use
- Model / Ref / Catalog
- 500434-100
- Primary DI / UDI-DI
- B207500434100
- 510(k) Number
- FDA product code
- BZG
- GMDN term
- Breathing mouthpiece, single-use
- Device class
- Class II
- Regulation number
- 868.1840
- GUDID distribution status
- In Commercial Distribution
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