Catalog Number

-

Brand Name

FlowArt®

Version/Model Number

3010L10

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"

Yes

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

K190806,K190806

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

25863043-0b24-47d8-8900-ad965eab5d63

Public Version Date

April 28, 2022

Public Version Number

1

DI Record Publish Date

April 20, 2022

Package DI Number

28699443585388

Quantity per Package

100

Contains DI Package

08699443585384

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box