AccessGUDID - DEVICE: Bebeonkers I (00815090010057)

GUDID

Device Identifier (DI) Information

Brand Name: Bebeonkers I
Version or Model: 16-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16-1
Company Name: SMALL BEGINNINGS INC

Primary DI Number: 00815090010057
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 002657679 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38749	Surgical/emergency suction cannula, non-illuminating, reusable	An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Bulbed End

Device Record Status

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