Catalog Number

MS440

Brand Name

MedStream

Version/Model Number

MS440

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

Yes

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

-

FDA Premarket Submission

K964435,K964435

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

44958574-ada9-41bb-9c4b-573432256319

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10842472100607

Quantity per Package

50

Contains DI Package

00842472100600

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-