Catalog Number

2000E

Brand Name

Alaris, SmartSite

Version/Model Number

2000E

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"

-

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

0b587696-eeed-4b4c-a18d-617c801f6449

Public Version Date

January 20, 2022

Public Version Number

6

DI Record Publish Date

September 22, 2016

Package DI Number

27613203013806

Quantity per Package

50

Contains DI Package

07613203011938

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfpack