Catalog Number

02342

Brand Name

VAKU-8+

Version/Model Number

21 G X ¾"

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

K000592,K000592,K000592,K000592

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

042e066f-0cdf-43d9-8faa-b92781602f13

Public Version Date

July 23, 2020

Public Version Number

5

DI Record Publish Date

April 26, 2017

Package DI Number

18903347023420

Quantity per Package

100

Contains DI Package

08903347023423

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX