Catalog Number

9251

Brand Name

Busse Hospital Disposables

Version/Model Number

9251

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"

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

NXA

Product Code Name

Tracheotomy Care Kit

Public Device Record Key

f991a13a-5c9a-4c87-af5e-dc1d8b766e55

Public Version Date

October 21, 2020

Public Version Number

2

DI Record Publish Date

April 08, 2020

Package DI Number

10849233011066

Quantity per Package

20

Contains DI Package

00849233011069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-