Catalog Number

-

Brand Name

Shiley

Version/Model Number

SSV

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

-

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

K945406,K945406

Product Code

BTO

Product Code Name

Tube, tracheostomy (w/wo connector)

Public Device Record Key

916e4cc9-9aa5-4ca7-9b0e-a3e1bff59ac1

Public Version Date

October 31, 2022

Public Version Number

6

DI Record Publish Date

September 02, 2015

Package DI Number

50884522005362

Quantity per Package

108

Contains DI Package

40884522005365

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE