Duns Number:002418234
Device Description: Bulb Tip Yankauer Suction Instrument without Vent with 6' X 1/4" ID Tubing
Catalog Number
302
Brand Name
Busse Hospital Disposables
Version/Model Number
302
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
GCX
Product Code Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Public Device Record Key
b7fee544-8d47-463b-bf65-53adbbbbe755
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
30849233013002
Quantity per Package
20
Contains DI Package
00849233013001
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |