Catalog Number

508

Brand Name

Busse Hospital Disposables

Version/Model Number

508

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Public Device Record Key

8db911f4-56ab-4bf6-97d0-b0cb03ee7013

Public Version Date

May 18, 2020

Public Version Number

1

DI Record Publish Date

May 08, 2020

Package DI Number

10849233012483

Quantity per Package

25

Contains DI Package

00849233012486

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-