Catalog Number

516.35

Brand Name

VYGON

Version/Model Number

516.35

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

K813373,K813373,K813373

Product Code

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Public Device Record Key

29693a30-6603-45a9-b56f-7f9fd771b7bf

Public Version Date

November 23, 2020

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

33660812005532

Quantity per Package

25

Contains DI Package

03660812005531

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-