Duns Number:013861471
Device Description: Male Luer Connector w/Caps
Catalog Number
MLC01
Brand Name
Male Luer Connector w/Caps
Version/Model Number
MLC
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"
Yes
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
K870188,K870188
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
be85a446-1c06-47b8-b8d2-89a5952825c1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
M991MLC012
Quantity per Package
32
Contains DI Package
M991MLC011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 239 |