Catalog Number

MV0400

Brand Name

SmartSite

Version/Model Number

MV0400

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

LHI

Product Code Name

Set, i.V. Fluid transfer

Public Device Record Key

7e7109cb-29de-459f-8575-901b0ba98488

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

50885403221642

Quantity per Package

100

Contains DI Package

10885403221644

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case