Duns Number:053469565
Device Description: Female - Female Luer Lock Connector, Sterile, Non-Pyrogenic, Individually Blister Packed, Female - Female Luer Lock Connector, Sterile, Non-Pyrogenic, Individually Blister Packed, Box of 100
Catalog Number
57-13
Brand Name
Female-Female Luer Lock
Version/Model Number
57-13
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
ce543b8b-e839-472f-9fca-9442206b4b04
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
August 22, 2016
Package DI Number
B21257132
Quantity per Package
100
Contains DI Package
B21257131
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |