Catalog Number

MPC-850

Brand Name

Molded Products, Inc.

Version/Model Number

MPC-850

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

Yes

Prescription Use (Rx)

-

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

7c2773a1-eec2-4caa-b310-c7080301265d

Public Version Date

September 12, 2019

Public Version Number

1

DI Record Publish Date

September 04, 2019

Package DI Number

B144MPC8503

Quantity per Package

30

Contains DI Package

B144MPC8501

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case