Duns Number:141668116
Device Description: Final Bacteria Filter - 1/4in to 1/2in
Catalog Number
BF1412-1
Brand Name
Final Bacteria Filter - 1/4in to 1/2in
Version/Model Number
BF1412-1
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"
Yes
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
JRL
Product Code Name
Unit, Filter, Membrane
Public Device Record Key
48de8baf-0c75-41c3-8d54-a92773949979
Public Version Date
June 25, 2018
Public Version Number
1
DI Record Publish Date
May 24, 2018
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 | 160 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |