Duns Number:080508772
Device Description: The Molekule Air Pro air purifier is a device intended for medical purposes that is used t The Molekule Air Pro air purifier is a device intended for medical purposes that is used to capture 95% of particulatematter and destroy bacteria, mold, and viruses by exposure to ultraviolet radiation when operated in Auto Mode Standardor manual mode at fan speed 2 or higher.
Catalog Number
-
Brand Name
Molekule Air Pro
Version/Model Number
SQ2P-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
K211194
Product Code
FRA
Product Code Name
Purifier, Air, Ultraviolet, Medical
Public Device Record Key
49e5c80d-210b-4e52-83a1-0f69719d74f7
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 02, 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 |