AccessGUDID - DEVICE: OtoClear® Tabletop WaterPik® Kit (00859911004856)

GUDID

Device Identifier (DI) Information

Brand Name: OtoClear® Tabletop WaterPik® Kit
Version or Model: 7240
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7240
Company Name: Bionix, LLC

Primary DI Number: 00859911004856
Issuing Agency: GS1
Commercial Distribution End Date: March 21, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 117844489 *Terms of Use

Device Description: Table Top WaterPik

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
46323	Ear canal lavage system	A device assembly designed for automated or semi-automated irrigation, washing, and extraction of tissue and/or debris from the ear canal. It typically consists of a main electromechanical unit that includes a pump for irrigation/infusion of a jet of non-medicated liquid (e.g., saline); controls for the rate and pressure of irrigation; a vacuum extractor, a reservoir for the solution; and a handpiece that may include a set of detachable tips intended for introduction into the ear canal. The system is mainly intended to remove debris (typically cerumen) to clean the ear canal for hygienic purposes, to improve hearing, and before procedures and/or surgery in or through the ear canal.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCP	SYRINGE, ENT

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: 843ed24f-dd0b-47e1-9972-2058db0d10df
Public Version Date: April 11, 2024
Public Version Number: 4
DI Record Publish Date: January 07, 2022