Catalog Number

-

Brand Name

Shiley

Version/Model Number

8DCP

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

K843730,K843730,K843730

Product Code

BTO

Product Code Name

Tube, tracheostomy (w/wo connector)

Public Device Record Key

2600de37-76b9-497f-9cc7-5ab6c92cb87d

Public Version Date

June 21, 2022

Public Version Number

5

DI Record Publish Date

August 31, 2015

Package DI Number

70884522005311

Quantity per Package

10

Contains DI Package

40884522005310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK