TrueTear F-0051

GUDID 00850102007151

TrueTear Gen 1.5 System

OCULEVE, INC.

Intranasal lacrimal neurostimulator
Primary Device ID00850102007151
NIH Device Record Key6ef80d1b-815a-4f56-ac8e-c0db45927b87
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrueTear
Version Model NumberF-0051
Catalog NumberF-0051
Company DUNS078797682
Company NameOCULEVE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(415)745-3784
Emailchung_susan@allergan.com
Phone+1(415)745-3784
Emailchung_susan@allergan.com
Phone+1(415)745-3784
Emailchung_susan@allergan.com
Phone+1(415)745-3784
Emailchung_susan@allergan.com
Phone+1(415)745-3784
Emailchung_susan@allergan.com
Phone+1(415)745-3784
Emailchung_susan@allergan.com
Phone+1(415)745-3784
Emailchung_susan@allergan.com
Phone+1(415)745-3784
Emailchung_susan@allergan.com
Phone+1(415)745-3784
Emailchung_susan@allergan.com
Phone+1(415)745-3784
Emailchung_susan@allergan.com
Phone+1(415)745-3784
Emailchung_susan@allergan.com
Phone+1(415)745-3784
Emailchung_susan@allergan.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850102007151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PQJIntranasal electrostimulation device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-15

On-Brand Devices [TrueTear]

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

Trademark Results [TrueTear]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRUETEAR
TRUETEAR
87373768 5382393 Live/Registered
Oculeve, Inc.
2017-03-16
TRUETEAR
TRUETEAR
87187737 5371139 Live/Registered
Oculeve, Inc.
2016-09-29
TRUETEAR
TRUETEAR
86931164 5287117 Live/Registered
Oculeve, Inc.
2016-03-07

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