Duns Number:103169095
Device Description: Airtime HEPA Filter Assembly Set, .010 micron Right Angle Connector - 1 package of 2 filte Airtime HEPA Filter Assembly Set, .010 micron Right Angle Connector - 1 package of 2 filters
Catalog Number
-
Brand Name
Airtime HEPA Filter Assembly Set, .010 micron Right Angle Connector
Version/Model Number
FLT-Y30
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
-
Product Code
JRJ
Product Code Name
Unit, Drying
Public Device Record Key
e32c0704-a284-4c23-ad44-656c02fd4af3
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
September 24, 2020
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 146 |