Catalog Number

-

Brand Name

Shiley

Version/Model Number

8DIC

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

K811447,K811447,K811447

Product Code

BTO

Product Code Name

Tube, tracheostomy (w/wo connector)

Public Device Record Key

a41320c2-0cf5-4c40-8fb4-8f8d0ddc7f1e

Public Version Date

June 21, 2022

Public Version Number

5

DI Record Publish Date

August 31, 2015

Package DI Number

40884522005327

Quantity per Package

10

Contains DI Package

50884522005324

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE