Catalog Number

MPC-774-W-EDPM

Brand Name

Molded Products, Inc.

Version/Model Number

MPC-774-W-EDPM

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

K022068,K022068

Product Code

FID

Product Code Name

Tubing, Dialysate

Public Device Record Key

65b3ddff-86db-4f6d-b215-e2e5a8e25db2

Public Version Date

October 12, 2022

Public Version Number

1

DI Record Publish Date

October 04, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-