Duns Number:157506015
Device Description: Barrier Adapter with Q Seal
Catalog Number
MPC-700-VI
Brand Name
Molded Products, Inc.
Version/Model Number
MPC-700-VI
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K010712,K010712,K010712
Product Code
FID
Product Code Name
Tubing, Dialysate
Public Device Record Key
2998cfea-f33f-446b-8df1-81e6108bdfbc
Public Version Date
September 12, 2019
Public Version Number
1
DI Record Publish Date
September 04, 2019
Package DI Number
B144MPC700VI3
Quantity per Package
10
Contains DI Package
B144MPC700VI1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
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 |