Duns Number:141668116
Device Description: 3B Luna Style Ultrafine Filter (1/pack)
Catalog Number
CF8005-1
Brand Name
3B Luna Style Ultrafine Filter
Version/Model Number
CF8005-1
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"
-
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
c5f0311b-fc28-47d0-b673-5add3d4afcd7
Public Version Date
July 05, 2018
Public Version Number
1
DI Record Publish Date
June 04, 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 |