Duns Number:002657679
Device Description: The Bebeonkers II Oral/Nasal Suction Device for the Ultra Preemie infant with Bebe Keeper The Bebeonkers II Oral/Nasal Suction Device for the Ultra Preemie infant with Bebe Keeper Kover 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. In between uses the Bebe Keeper Kover can be placed over suction tip to keep clean. Each unit contains one suction tip and one cover.
Catalog Number
16-2KK
Brand Name
Bebeonkers II
Version/Model Number
16-2KK
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
e9aea60b-e9d8-4458-82a8-f2dfae47d7b9
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20815090011386
Quantity per Package
4
Contains DI Package
10815090011389
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case