Catalog Number

1013303

Brand Name

VisIV

Version/Model Number

1013303

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

-

Product Code

KPE

Product Code Name

CONTAINER, I.V.

Public Device Record Key

5bfad516-bcb3-4499-8b60-201710e6b3f7

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

December 02, 2016

Package DI Number

20887787001833

Quantity per Package

10

Contains DI Package

10887787001836

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case