Catalog Number

MPC-855S.250PP

Brand Name

Molded Products, Inc.

Version/Model Number

MPC-855S.250PP

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,K003712

Product Code

KOC

Product Code Name

Accessories, Blood Circuit, Hemodialysis

Public Device Record Key

7939dd9e-3dce-4678-99aa-64d953fd0cd6

Public Version Date

September 11, 2019

Public Version Number

1

DI Record Publish Date

September 03, 2019

Package DI Number

B144MPC855S250PP5

Quantity per Package

10

Contains DI Package

B144MPC855S250PP4

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case