Catalog Number

11501183

Brand Name

Alaris, VersaSafe

Version/Model Number

11501183

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

2129bdd4-03c4-4b4a-8bc2-ae6b24993985

Public Version Date

March 17, 2021

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

70885403422272

Quantity per Package

60

Contains DI Package

50885403422278

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pallet