TrueTear F-0051

GUDID 00850102007151

TrueTear Gen 1.5 System

OCULEVE, INC.

Intranasal lacrimal neurostimulator Intranasal lacrimal electrical neurostimulator Intranasal lacrimal electrical neurostimulator Intranasal lacrimal electrical neurostimulator Intranasal lacrimal electrical neurostimulator Intranasal lacrimal electrical neurostimulator Intranasal lacrimal electrical neurostimulator Intranasal lacrimal electrical neurostimulator Intranasal lacrimal electrical neurostimulator Intranasal lacrimal electrical neurostimulator Intranasal lacrimal electrical neurostimulator Intranasal lacrimal electrical 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