Catalog Number

MPC-825-S

Brand Name

Molded Products, Inc.

Version/Model Number

MPC-825-S

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K003712,K003712,K003712

Product Code

KOC

Product Code Name

Accessories, Blood Circuit, Hemodialysis

Public Device Record Key

74ad7ce3-b8a5-4227-8954-6c5c03488881

Public Version Date

October 12, 2022

Public Version Number

1

DI Record Publish Date

October 04, 2022

Package DI Number

B144MPC825S1

Quantity per Package

25

Contains DI Package

B144MPC825S0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag