Catalog Number

8209R1

Brand Name

Busse Hospital Disposables

Version/Model Number

8209R1

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

CAZ

Product Code Name

Anesthesia Conduction Kit

Public Device Record Key

1e97e1f0-b2d8-43f2-a86c-8b8a0705d0e8

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

10849233016689

Quantity per Package

50

Contains DI Package

00849233016682

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-