Catalog Number

10013365

Brand Name

Alaris, SmartSite

Version/Model Number

10013365

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

c8236988-edeb-471a-9b12-2a4f7bdcd3c0

Public Version Date

May 19, 2020

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

37613203010420

Quantity per Package

4

Contains DI Package

27613203013912

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case