Catalog Number

MS428

Brand Name

MedStream

Version/Model Number

MS428

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

b3ca14f3-25cf-42f0-8e7d-79a6d14fd762

Public Version Date

May 11, 2018

Public Version Number

1

DI Record Publish Date

April 10, 2018

Package DI Number

10842472100379

Quantity per Package

100

Contains DI Package

00842472100372

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-