FDA.reportPublic FDA data

TrueTear

Primary DI
00850102007038
Brand
TrueTear
Company
OCULEVE, INC.
Model
F-0031
Catalog number
F-0031
Device description
TrueTear System
Published
2017-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PQJIntranasal electrostimulation device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQJIntranasal Electrostimulation DeviceOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850102007038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850102007038008501020070388501020070380850102007038

GMDN Terms#

Term, Definition table
TermDefinition
Intranasal lacrimal neurostimulatorA battery-powered, hand-held device intended to be used in the home to provide electrical stimulation to sensory neurons of the nasal cavities to acutely increase tear production as treatment for aqueous deficient dry eye. It is a portable electronic unit onto which disposable electrode tips are mounted and then inserted into the nostrils to deliver the electrical stimuli. A charger and lid are typically included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(415)745-3784chung_susan@allergan.com

Regulatory Flags#

DUNS number
078797682
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850102007106TrueTearF-0036F-00362017-06-29
00850102007120TrueTearF-0035F-00352017-06-29
00850102007137TrueTearF-0030F-00302017-06-29
00850102007151TrueTearF-0051F-00512018-02-15
00850102007168TrueTearF-0056F-00562018-02-15
00850102007175TrueTearF-0055F-00552018-02-15
00850102007182TrueTearF-0050F-00502018-02-15
00850102007113TrueTearF-0037F-00372017-06-29
00850102007199TrueTearF-0057F-00572018-02-15
00850102007144TrueTearF-0039F-00392017-06-29
00850102007205TrueTearF-0059F-00592018-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850102007151TrueTearOCULEVE, INC.PQJ2018-02-15
00850102007168TrueTearOCULEVE, INC.PQJ2018-02-15
00850102007175TrueTearOCULEVE, INC.PQJ2018-02-15
00850102007182TrueTearOCULEVE, INC.PQJ2018-02-15
00850102007199TrueTearOCULEVE, INC.PQJ2018-02-15
00850102007205TrueTearOCULEVE, INC.PQJ2018-02-15
00850102007106TrueTearOCULEVE, INC.PQJ2017-06-29
00850102007113TrueTearOCULEVE, INC.PQJ2017-06-29
00850102007120TrueTearOCULEVE, INC.PQJ2017-06-29
00850102007137TrueTearOCULEVE, INC.PQJ2017-06-29
00850102007144TrueTearOCULEVE, INC.PQJ2017-06-29