Duns Number:002657679
Device Description: The Bebeonkers I Oral/Nasal Suction Device is intended to be attached to wall suction and The Bebeonkers I Oral/Nasal Suction Device is intended to be attached to wall suction and used as an oral or nasal cavity evacuator to remove secretions and maintain a clear airway.
Catalog Number
16-1
Brand Name
Bebeonkers I
Version/Model Number
16-1
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
b2fea0e8-81f4-4f57-a648-822eb80e1d11
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20815090010051
Quantity per Package
6
Contains DI Package
10815090010054
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case