Catalog Number

00131005

Brand Name

VYGON

Version/Model Number

1310.05

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KNT

Product Code Name

Tubes, gastrointestinal (and accessories)

Public Device Record Key

1212ae12-1079-4dc5-a72d-ecbaf4fcc891

Public Version Date

April 04, 2022

Public Version Number

1

DI Record Publish Date

March 25, 2022

Package DI Number

33660812142572

Quantity per Package

25

Contains DI Package

03660812142571

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box