Catalog Number

-

Brand Name

Resp-O2 Closed Suction Tracheostomy Catheter

Version/Model Number

31000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

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

-

Product Code

BSY

Product Code Name

Catheters, Suction, Tracheobronchial

Public Device Record Key

6ed83b38-ae6d-4fc6-8f91-0c367dc5c89b

Public Version Date

April 30, 2021

Public Version Number

1

DI Record Publish Date

April 22, 2021

Package DI Number

00840117319554

Quantity per Package

2

Contains DI Package

00840117319547

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case