Catalog Number

-

Brand Name

Resp-O2 Endotracheal Tube with Stylette, Cuffed, 4.0 mm

Version/Model Number

36245

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K042683,K042683,K042683

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

ccf0e0e9-0759-4fcd-a607-5a066e4cade6

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 15, 2022

Package DI Number

00840117313125

Quantity per Package

10

Contains DI Package

00840117317567

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box