SaliPen

Basic Information

• Brand Name: SaliPen
• Primary DI: 07290014891005
• Version / Model: OTC
• Company Name: SALIWELL LTD
• Labeler DUNS: 533732749
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-03
• Public Version: 1
• Public Version Date: 2024-07-11
• Public Version Status: New
• Public Device Record Key: fd2d8f04-b436-4ddd-94ea-164e2924dd2f
• Distribution End Date: 2033-07-17

Device Description

SaliPen is an electrostimulating device aimed at treating dry mouth.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QTT	Over The Counter Electrical Salivary Stimulatory System	Dental	872.5560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58162	Dry mouth saliva electrical stimulator	A battery-powered device intended to apply electrical current directly to the soft tissue in the mouth of a patient to stimulate a sensorial nerve for increased secretion of saliva from the salivary glands to treat dry mouth condition (xerostomia). It passes a low electric current pulse-train via its integrated electrodes intended to generate an electromagnetic (EM) field around the targeted nerve. The device is activated by the patient with an integrated control or included remote control. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290014891005	GS1