AccessGUDID - DEVICE: ClearUP Sinus Pain Relief (00850006251032)

GUDID

Device Identifier (DI) Information

Brand Name: ClearUP Sinus Pain Relief
Version or Model: SN200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SN200
Company Name: TIVIC HEALTH SYSTEMS INC.

Primary DI Number: 00850006251032
Issuing Agency: GS1
Commercial Distribution End Date: October 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 080598314 *Terms of Use

Device Description: ClearUP Sinus Relief Device 2.0

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	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?
60682	Craniofacial analgesia electrical stimulator	A non-sterile, battery-powered device designed to non-invasively stimulate nerves of the head/face to prevent or treat headaches (including migraine) and/or frontal sinus pain; it may also be used to treat insomnia. It is a patient worn or hand-held device which typically consists of one or more electrodes designed to be placed on the forehead or other parts of the face, and a pulse generator to provide the electric current. The device is typically used by a patient in the home and the therapy may be referred to as neurostimulation or transcutaneous electrical stimulation (TENS). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QNU	Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 66dad1cf-b266-48a1-a2ee-88e9da107d31
Public Version Date: October 31, 2023
Public Version Number: 2
DI Record Publish Date: October 18, 2023