TrueTear F-0051

GUDID 00850102007151

TrueTear Gen 1.5 System

OCULEVE, INC.

Intranasal lacrimal neurostimulator

• Primary Device ID: 00850102007151
• NIH Device Record Key: 6ef80d1b-815a-4f56-ac8e-c0db45927b87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrueTear
• Version Model Number: F-0051
• Catalog Number: F-0051
• Company DUNS: 078797682
• Company Name: OCULEVE, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(415)745-3784
• Email: chung_susan@allergan.com
• Phone: +1(415)745-3784
• Email: chung_susan@allergan.com
• Phone: +1(415)745-3784
• Email: chung_susan@allergan.com
• Phone: +1(415)745-3784
• Email: chung_susan@allergan.com
• Phone: +1(415)745-3784
• Email: chung_susan@allergan.com
• Phone: +1(415)745-3784
• Email: chung_susan@allergan.com
• Phone: +1(415)745-3784
• Email: chung_susan@allergan.com
• Phone: +1(415)745-3784
• Email: chung_susan@allergan.com
• Phone: +1(415)745-3784
• Email: chung_susan@allergan.com
• Phone: +1(415)745-3784
• Email: chung_susan@allergan.com
• Phone: +1(415)745-3784
• Email: chung_susan@allergan.com
• Phone: +1(415)745-3784
• Email: chung_susan@allergan.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850102007151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN160030

FDA Product Code

• PQJ: Intranasal electrostimulation device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-15

On-Brand Devices [TrueTear]

• 00850102007205: TrueTear Gen 1.5 Cover Kit
• 00850102007199: TrueTear Gen 1.5 Charger Kit
• 00850102007182: TrueTear Gen 1.5 Disposable Tip
• 00850102007175: TrueTear Gen 1.5 Disposable Tip Demo
• 00850102007168: TrueTear Gen 1.5 System Demo
• 00850102007151: TrueTear Gen 1.5 System
• 00850102007144: TrueTear Cover Kit
• 00850102007137: TrueTear Disposable Tip
• 00850102007120: TrueTear Disposable Tip Demo
• 00850102007113: TrueTear Charger Kit
• 00850102007106: TrueTear System Demo
• 00850102007038: TrueTear System