Duns Number:157506015
Device Description: Sterile DIN to DIN Connector with Sampling Port
Catalog Number
MPC-850-SP
Brand Name
Molded Products, Inc.
Version/Model Number
MPC-850-SP
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
K003712,K003712,K003712
Product Code
KOC
Product Code Name
Accessories, Blood Circuit, Hemodialysis
Public Device Record Key
7372740c-7c32-450c-9f14-2e3113aed3c6
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
December 16, 2016
Package DI Number
B144MPC850SP3
Quantity per Package
30
Contains DI Package
B144MPC850SP1
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 |