FDA.reportPublic FDA data

TrueTear

Primary DI
00850102007199
Brand
TrueTear
Company
OCULEVE, INC.
Model
F-0057
Catalog number
F-0057
Device description
TrueTear Gen 1.5 Charger Kit
Published
2018-02-15
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN160030000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN160030000Oculeve Intranasal Tear Neurostimulator DeviceOculeve, Inc.2017-04-24PQJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850102007199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850102007199008501020071998501020071990850102007199

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

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
00850102007038TrueTearF-0031F-00312017-06-29
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
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
00850102007205TrueTearOCULEVE, INC.PQJ2018-02-15
00850102007038TrueTearOCULEVE, INC.PQJ2017-06-29
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