Duns Number:796083392
Catalog Number
-
Brand Name
Luer Fitting Female
Version/Model Number
BF00-0010
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
MON
Product Code Name
System, Hemodialysis, Remote Accessories
Public Device Record Key
4908e76d-f77e-405a-bf2b-af9e7252d15d
Public Version Date
September 09, 2019
Public Version Number
1
DI Record Publish Date
August 30, 2019
Package DI Number
10858293006455
Quantity per Package
10
Contains DI Package
00858293006458
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 30 |
2 | A medical device with a moderate to high risk that requires special controls. | 46 |