Catalog Number

MPC-60B

Brand Name

Molded Products, Inc.

Version/Model Number

MPC-60B

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

K010366,K010366,K010366

Product Code

FJI

Product Code Name

Dialyzer, Capillary, Hollow Fiber

Public Device Record Key

20d6a13e-d65b-493b-813b-2d282b078b48

Public Version Date

September 12, 2019

Public Version Number

1

DI Record Publish Date

September 04, 2019

Package DI Number

B144MPC60B3

Quantity per Package

100

Contains DI Package

B144MPC60B1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case