Home GUDID 00850102007137 TrueTear
Primary DI 00850102007137
Brand TrueTear
Company OCULEVE, INC.
Model F-0030
Catalog number F-0030
Device description TrueTear Disposable Tip
Published 2017-06-29
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name PQJ Intranasal electrostimulation device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PQJ Intranasal Electrostimulation Device Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850102007137 Primary GS1 0 10850102007134 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850102007137 00850102007137 850102007137 0850102007137 10850102007134 10850102007134
GMDN Terms# Term, Definition table Term Definition Intranasal lacrimal neurostimulator electrode An electrical conductor designed to be attached to a hand-held intranasal lacrimal neurostimulator to deliver electrical stimuli to sensory neurons of the nasal cavities to acutely increase tear production as treatment for aqueous deficient dry eye. It is a double-pronged device, made of metal and synthetic polymer materials (e.g., hydrogel), intended to be inserted into the nostrils. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 5 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 078797682 Device count 30 DM exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850102007151 TrueTear OCULEVE, INC. PQJ 2018-02-15 00850102007168 TrueTear OCULEVE, INC. PQJ 2018-02-15 00850102007175 TrueTear OCULEVE, INC. PQJ 2018-02-15 00850102007182 TrueTear OCULEVE, INC. PQJ 2018-02-15 00850102007199 TrueTear OCULEVE, INC. PQJ 2018-02-15 00850102007205 TrueTear OCULEVE, INC. PQJ 2018-02-15 00850102007038 TrueTear OCULEVE, INC. PQJ 2017-06-29 00850102007106 TrueTear OCULEVE, INC. PQJ 2017-06-29 00850102007113 TrueTear OCULEVE, INC. PQJ 2017-06-29 00850102007120 TrueTear OCULEVE, INC. PQJ 2017-06-29 00850102007144 TrueTear OCULEVE, INC. PQJ 2017-06-29
allergan.com