Duns Number:117749345
Device Description: Medical Ultraviolet Air Cleaner
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
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |