Duns Number:080508772
Device Description: The Molekule Air Mini air purifier is a device intended for medical purposes that is used The Molekule Air Mini air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation
Catalog Number
-
Brand Name
Molekule Air Mini +
Version/Model Number
MN1P-US
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K202339
Product Code
FRA
Product Code Name
Purifier, Air, Ultraviolet, Medical
Public Device Record Key
8d2657c5-2d1b-4d58-8a9d-691c93830232
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
February 25, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |