Catalog Number

363.042

Brand Name

VYGON

Version/Model Number

363.042

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

88fef955-0f9b-478b-be14-e9bfa2c3bd26

Public Version Date

October 04, 2019

Public Version Number

1

DI Record Publish Date

September 26, 2019

Package DI Number

53660812114306

Quantity per Package

24

Contains DI Package

33660812114302

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case