Catalog Number

11619427

Brand Name

Alaris, SmartSite

Version/Model Number

11619427

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

e4b6cbed-df05-4b5d-8c02-f57abd0a24ec

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

February 07, 2017

Package DI Number

70885403422289

Quantity per Package

144

Contains DI Package

50885403422285

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pallet