Vapor Clean 10000
by Dynasthetics United States GUDID
Product code CBN
Regulatory status
Recall ongoing. 1 ongoing FDA recall. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00858545007004 | Date14 Sep 2017 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — GUDID listing Listed
Recalls
-
- Ongoing Z-1591-2023
Due to a manufacturing issue that may result in filter leakage.
Specification
- Trade Name
- Vapor Clean
- Generic Name
- Halogenated vapour absorber
- Model / Reference
- 10000
- Primary DI / UDI-DI
- 00858545007004
- 510(k) Number
- FDA Product Code
- CBN
- GMDN Term
- Halogenated vapour absorber
- Device Class
- Class II
- Regulation Number
- 868.5430
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Safe
Other devices from Dynasthetics
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No
Sources (1)
- FDA UDI e7f968eb-04c5-40f8-85e0-f2e5ed304a55