Catalog Number

MS984

Brand Name

MedStream

Version/Model Number

MS984

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

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

abeef991-84f0-4ee1-81e9-45d2b31d7527

Public Version Date

May 19, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

10842472100829

Quantity per Package

100

Contains DI Package

00842472100822

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-