Molekule - The Molekule Air Pro RX air purifier is a device - MOLEKULE, INC.

Duns Number:080508772

Device Description: The Molekule Air Pro RX air purifier is a device intended for medical purposes that is use The Molekule Air Pro RX 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

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More Product Details

Catalog Number

-

Brand Name

Molekule

Version/Model Number

Air Pro RX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K200500

Product Code Details

Product Code

FRA

Product Code Name

Purifier, Air, Ultraviolet, Medical

Device Record Status

Public Device Record Key

86fcc3db-dff0-4c32-a0c8-fb7703245d08

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

October 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MOLEKULE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5