TrueTear

Primary DI: 00850102007182
Brand: TrueTear
Company: OCULEVE, INC.
Model: F-0050
Catalog number: F-0050
Device description: TrueTear Gen 1.5 Disposable Tip
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#

allergan.com

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

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
DEN160030	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
DEN160030	000	Oculeve Intranasal Tear Neurostimulator Device	Oculeve, Inc.	2017-04-24	PQJ

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00850102007182	Primary	GS1	0
10850102007189	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
00850102007182	00850102007182	850102007182	0850102007182
10850102007189	10850102007189

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number: 078797682
Device count: 15
DM exempt: true
Lot or batch: true
Expiration date on label: true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00850102007038	TrueTear	F-0031	F-0031	2017-06-29
00850102007106	TrueTear	F-0036	F-0036	2017-06-29
00850102007120	TrueTear	F-0035	F-0035	2017-06-29
00850102007137	TrueTear	F-0030	F-0030	2017-06-29
00850102007151	TrueTear	F-0051	F-0051	2018-02-15
00850102007168	TrueTear	F-0056	F-0056	2018-02-15
00850102007175	TrueTear	F-0055	F-0055	2018-02-15
00850102007113	TrueTear	F-0037	F-0037	2017-06-29
00850102007199	TrueTear	F-0057	F-0057	2018-02-15
00850102007144	TrueTear	F-0039	F-0039	2017-06-29
00850102007205	TrueTear	F-0059	F-0059	2018-02-15

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
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
00850102007137	TrueTear	OCULEVE, INC.	PQJ	2017-06-29
00850102007144	TrueTear	OCULEVE, INC.	PQJ	2017-06-29