Catalog Number

-

Brand Name

Shiley

Version/Model Number

SSVO

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

K945407,K945407,K945407

Product Code

BTO

Product Code Name

Tube, tracheostomy (w/wo connector)

Public Device Record Key

7ac3b0b3-d1fb-4f86-b2e4-dab2304a7a5c

Public Version Date

May 27, 2022

Public Version Number

5

DI Record Publish Date

February 06, 2018

Package DI Number

20884521751368

Quantity per Package

2

Contains DI Package

10884521751361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK