Catalog Number

MPC-825

Brand Name

Molded Products, Inc.

Version/Model Number

MPC-825

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

K010712,K010712,K010712

Product Code

FID

Product Code Name

Tubing, Dialysate

Public Device Record Key

6879ac6a-8578-4f54-9b96-e8f02a21d91b

Public Version Date

September 12, 2019

Public Version Number

1

DI Record Publish Date

September 04, 2019

Package DI Number

B144MPC8253

Quantity per Package

6

Contains DI Package

B144MPC8251

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case