Catalog Number

5534.91

Brand Name

VYGON

Version/Model Number

5534.91

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

d6a6fcbb-1dfd-4f49-8568-8b72e95f4f10

Public Version Date

October 22, 2018

Public Version Number

3

DI Record Publish Date

February 28, 2018

Package DI Number

33660812019102

Quantity per Package

25

Contains DI Package

03660812019101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box