Catalog Number

VF HC

Brand Name

MEDRAD® Vflow Disposable Hand Controller

Version/Model Number

VF HC

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

K132928,K132928

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

567f296a-ac66-4785-8dcc-9c714c84053c

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

October 25, 2019

Package DI Number

40616258021643

Quantity per Package

25

Contains DI Package

00616258021645

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-