Catalog Number

-

Brand Name

Shiley

Version/Model Number

10SIC

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

K930895,K930895,K930895

Product Code

JOH

Product Code Name

Tube tracheostomy and tube cuff

Public Device Record Key

881811e9-0af1-46f4-a527-d7c2751dcfab

Public Version Date

May 27, 2022

Public Version Number

5

DI Record Publish Date

August 28, 2015

Package DI Number

70884522005229

Quantity per Package

24

Contains DI Package

10884522005227

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE