Catalog Number

00819355020218

Brand Name

The Pyure Company

Version/Model Number

MDU/RX

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K133800

Product Code

FRA

Product Code Name

Purifier, Air, Ultraviolet, Medical

Public Device Record Key

f77a3f29-903a-41a7-8d48-2b9e79cb106e

Public Version Date

April 20, 2021

Public Version Number

1

DI Record Publish Date

April 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-