Catalog Number

10010983

Brand Name

Alaris, SmartSite

Version/Model Number

10010983

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

6b4a0a43-2be5-45bd-be4d-eb320a8dd4a0

Public Version Date

January 17, 2022

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

50885403233577

Quantity per Package

100

Contains DI Package

10885403233579

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfpack