Catalog Number

5516.40

Brand Name

VYGON

Version/Model Number

5516.40

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

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Public Device Record Key

81cee7d5-6217-4999-aca6-c25e013cdff6

Public Version Date

June 19, 2020

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

53660812018871

Quantity per Package

8

Contains DI Package

33660812018877

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-