Catalog Number

368.22

Brand Name

VYGON

Version/Model Number

368.22

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

FPD

Product Code Name

TUBE, FEEDING

Public Device Record Key

a53f20a4-be3f-4e70-8679-dbc51949eeb7

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

January 12, 2018

Package DI Number

53660812098330

Quantity per Package

96

Contains DI Package

33660812098336

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case