Duns Number:002418234
Device Description: 10' X 1/4" ID Suction Tubing
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
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
BYY
Product Code Name
Tube, Aspirating, Flexible, Connecting
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
Package DI Number
40849233012934
Quantity per Package
50
Contains DI Package
00849233012936
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 |