Duns Number:157506015
Device Description: Male to Male Luer Adapter
Catalog Number
MPC-155
Brand Name
Molded Products, Inc.
Version/Model Number
MPC-155
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
K003712,K003712,K003712
Product Code
KOC
Product Code Name
Accessories, Blood Circuit, Hemodialysis
Public Device Record Key
5090cd48-4fd0-476e-8f21-06c6f734f19a
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
January 05, 2018
Package DI Number
B144MPC1553
Quantity per Package
40
Contains DI Package
B144MPC1551
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |