Catalog Number

MPC-100-S

Brand Name

Molded Products, Inc

Version/Model Number

MPC-100-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"

Yes

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

K925927,K925927,K925927,K925927

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

10d96ecc-a706-4fec-8418-d274a159aed9

Public Version Date

October 12, 2022

Public Version Number

1

DI Record Publish Date

October 04, 2022

Package DI Number

B144MPC100S1

Quantity per Package

100

Contains DI Package

B144MPC100S0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag