Catalog Number

00556601

Brand Name

VYGON

Version/Model Number

5566.01

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

CAN

Product Code Name

REGULATOR, PRESSURE, GAS CYLINDER

Public Device Record Key

eb47a9d4-995d-416d-b15d-a34d3f806097

Public Version Date

June 17, 2021

Public Version Number

1

DI Record Publish Date

June 09, 2021

Package DI Number

33660812115842

Quantity per Package

5

Contains DI Package

03660812115841

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box