Busse Hospital Disposables - 10' X 1/4" ID Suction Tubing - ROBERT BUSSE & CO., INC.

Duns Number:002418234

Device Description: 10' X 1/4" ID Suction Tubing

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More Product Details

Catalog Number

155

Brand Name

Busse Hospital Disposables

Version/Model Number

155

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

BYY

Product Code Name

Tube, Aspirating, Flexible, Connecting

Device Record Status

Public Device Record Key

d57a8f3b-aa75-4d82-8d4f-4d65520f2af8

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

40849233012934

Quantity per Package

50

Contains DI Package

00849233012936

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