Catalog Number

362.122

Brand Name

VYGON

Version/Model Number

362.122

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

a7ce6de6-00b3-42ce-a81f-ac438cf954f2

Public Version Date

August 16, 2021

Public Version Number

1

DI Record Publish Date

August 06, 2021

Package DI Number

33660812129986

Quantity per Package

25

Contains DI Package

03660812129985

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box