Catalog Number

MPC-1405

Brand Name

Molded Products, Inc.

Version/Model Number

MPC-1405

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

b934a6d5-6b12-4445-973c-be8d6f2446ac

Public Version Date

September 12, 2019

Public Version Number

1

DI Record Publish Date

September 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-