Catalog Number

VED-032

Brand Name

NA

Version/Model Number

VED-032

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 29, 2022

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

K132424,K132424

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

54940502-c4a1-4193-a0cb-be059f593117

Public Version Date

August 01, 2022

Public Version Number

5

DI Record Publish Date

October 15, 2016

Package DI Number

50812496010310

Quantity per Package

30

Contains DI Package

00812496010315

Package Discontinue Date

July 29, 2022

Package Status

Not in Commercial Distribution

Package Type

Cardboard Carton