Catalog Number

1292

Brand Name

Busse Hospital Disposables

Version/Model Number

1292

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

OBJ

Product Code Name

Catheter, Ultrasound, Intravascular

Public Device Record Key

a8998bf4-0ead-4de6-89e3-b2c86ff1ce4a

Public Version Date

April 15, 2020

Public Version Number

1

DI Record Publish Date

April 07, 2020

Package DI Number

10849233003641

Quantity per Package

10

Contains DI Package

00849233003644

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-