Catalog Number

-

Brand Name

McKesson

Version/Model Number

5028

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)

Yes

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

-

Product Code

BSY

Product Code Name

Catheters, Suction, Tracheobronchial

Public Device Record Key

7489a4ef-456e-4913-8ccd-9b0826cf4f29

Public Version Date

July 23, 2020

Public Version Number

1

DI Record Publish Date

July 15, 2020

Package DI Number

40612479204025

Quantity per Package

50

Contains DI Package

10612479204017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case