Busse Hospital Disposables - Universal - ROBERT BUSSE & CO., INC.

Duns Number:002418234

Device Description: Universal

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More Product Details

Catalog Number

8599

Brand Name

Busse Hospital Disposables

Version/Model Number

8599

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

CAZ

Product Code Name

Anesthesia Conduction Kit

Device Record Status

Public Device Record Key

5863c6ec-9062-4651-8142-de8d73c1b501

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

10849233017143

Quantity per Package

10

Contains DI Package

00849233017146

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ROBERT BUSSE & CO., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 298