Catalog Number

000362142

Brand Name

VYGON

Version/Model Number

362.142

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

ab225944-41c1-43b5-a676-f66c0b9d29b1

Public Version Date

June 17, 2022

Public Version Number

1

DI Record Publish Date

June 09, 2022

Package DI Number

33660812137912

Quantity per Package

50

Contains DI Package

03660812137911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box