Duns Number:157506015
Device Description: Female Luer Lock - White - Replacement Cap
Catalog Number
MPC-115
Brand Name
Molded Products, Inc.
Version/Model Number
MPC-115
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
K925927,K925927,K925927,K925927
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
c67cb58d-a5b8-4605-8dc4-e8e8236afe72
Public Version Date
September 09, 2020
Public Version Number
5
DI Record Publish Date
January 04, 2018
Package DI Number
B144MPC1153
Quantity per Package
25
Contains DI Package
B144MPC1152
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 24 |