TrueTear

Basic Information

• Brand Name: TrueTear
• Primary DI: 00850102007038
• Version / Model: F-0031
• Catalog Number: F-0031
• Company Name: OCULEVE, INC.
• Labeler DUNS: 078797682
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-29
• Public Version: 3
• Public Version Date: 2021-05-24
• Public Version Status: Update
• Public Device Record Key: f07cf80b-4485-4162-871d-a9860a6e36d7

Device Description

TrueTear System

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PQJ	Intranasal electrostimulation device	Ophthalmic	886.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62548	Intranasal lacrimal electrical neurostimulator	A battery-powered, hand-held device intended to be used in the home to provide electrical stimulation to sensory neurons of the nasal cavities to acutely increase tear production as treatment for aqueous deficient dry eye. It is a portable electronic unit onto which disposable electrode tips are mounted and then inserted into the nostrils to deliver the electrical stimuli. A charger and lid are typically included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850102007038	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius