TrueTear

Basic Information

• Brand Name: TrueTear
• Primary DI: 00850102007205
• Version / Model: F-0059
• Catalog Number: F-0059
• Company Name: OCULEVE, INC.
• Labeler DUNS: 078797682
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-15
• Public Version: 4
• Public Version Date: 2019-02-21
• Public Version Status: Update
• Public Device Record Key: a49cc156-004e-4b5a-8014-d7bf98021066

Device Description

TrueTear Gen 1.5 Cover Kit

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
62722	Electronic device storage cover, reusable	A non-sterile device intended to cover a portable electronic medical device while it is not in use to protect it from damage/contamination. The cover is often shaped for a specific type of portable electronic device and is intended to be removed before electronic device use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850102007205	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN160030	000

Storage Conditions

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