Catalog Number

00053512

Brand Name

VYGON

Version/Model Number

535.12

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

BSY

Product Code Name

CATHETERS, SUCTION, TRACHEOBRONCHIAL

Public Device Record Key

72ce834e-1417-4506-9080-d1908104cfc6

Public Version Date

June 17, 2021

Public Version Number

1

DI Record Publish Date

June 09, 2021

Package DI Number

53660812126897

Quantity per Package

9

Contains DI Package

33660812126893

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case