Duns Number:157506015
Device Description: Intermittent Injection Cap
Catalog Number
MPC-100
Brand Name
Molded Products, Inc.
Version/Model Number
MPC-100
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
K925927,K925927,K925927,K925927
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
a01f0ac7-a2cb-41d1-9b70-2060bc52200d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 08, 2016
Package DI Number
B144MPC1003
Quantity per Package
25
Contains DI Package
B144MPC1002
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 |