Catalog Number

20053E

Brand Name

Alaris, SmartSite

Version/Model Number

20053E

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

a688aa56-7a03-4d13-9c4a-8846cc1b2573

Public Version Date

April 27, 2020

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

50885403234888

Quantity per Package

4

Contains DI Package

20885403234887

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case