AccessGUDID - DEVICE: bebird (00850030574060)

GUDID

Device Identifier (DI) Information

Brand Name: bebird
Version or Model: W3-WM-BK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HVRS
Company Name: Be Bird Usa, Inc

Primary DI Number: 00850030574060
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117929555 *Terms of Use

Device Description: Ear Wax Removal System. View and safely clean your ear canal. The bebird cleaning rod wireless connects to your apple or android phone or tablet allowing the user to see high resolution images of their outer ear canal.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
44929	Otoscope, endoscopic	An endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle typically with images displayed on a monitor. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ERA	Otoscope

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
No Device Sizes

Device Record Status

Public Device Record Key: ce85f8b4-22d6-49b5-a3e9-6f9be06dc40c
Public Version Date: August 30, 2021
Public Version Number: 1
DI Record Publish Date: August 20, 2021