Catalog Number

MPC-665

Brand Name

Molded Products, Inc.

Version/Model Number

MPC-665

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

K010712,K010712,K010712

Product Code

FID

Product Code Name

Tubing, Dialysate

Public Device Record Key

e151ff46-2655-41e7-90d2-e31533add4c8

Public Version Date

September 12, 2019

Public Version Number

1

DI Record Publish Date

September 04, 2019

Package DI Number

B144MPC6653

Quantity per Package

16

Contains DI Package

B144MPC6651

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case