Catalog Number

368.42R

Brand Name

VYGON

Version/Model Number

368.42R

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K060944,K060944

Product Code

KNT

Product Code Name

Tubes, gastrointestinal (and accessories)

Public Device Record Key

912e03af-bffc-4378-a874-870491c75878

Public Version Date

September 28, 2022

Public Version Number

1

DI Record Publish Date

September 20, 2022

Package DI Number

30849884002394

Quantity per Package

100

Contains DI Package

00849884002393

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-