Catalog Number

-

Brand Name

Resp-O2 Endotracheal Tube With Stylette Cuffed, 7.0 mm

Version/Model Number

36251

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

3b49b939-94d8-4011-b1db-fbd490e7c2b7

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 15, 2022

Package DI Number

00840117313248

Quantity per Package

10

Contains DI Package

00840117317628

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box