Duns Number:157506015
Device Description: DIALYZER HOLDER - fits 18mm to 22mm IV Pole
Catalog Number
MPC-1400A
Brand Name
Molded Products, Inc.
Version/Model Number
MPC-1400A
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
-
Product Code
MON
Product Code Name
System, Hemodialysis, Remote Accessories
Public Device Record Key
cde975ab-3dc8-4cf9-a834-16fed4363ec4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 29, 2016
Package DI Number
B144MPC1400A3
Quantity per Package
15
Contains DI Package
B144MPC1400A2
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 |