The Pyure Company - Medical Ultraviolet Air Cleaner - The Pyure Company Inc

Duns Number:117749345

Device Description: Medical Ultraviolet Air Cleaner

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More Product Details

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

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K133800

Product Code Details

Product Code

FRA

Product Code Name

Purifier, Air, Ultraviolet, Medical

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THE PYURE COMPANY INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1