AccessGUDID - DEVICE: TrueTear (00850102007151)

GUDID

Device Identifier (DI) Information

Brand Name: TrueTear
Version or Model: F-0051
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F-0051
Company Name: OCULEVE, INC.

Primary DI Number: 00850102007151
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078797682 *Terms of Use

Device Description: TrueTear Gen 1.5 System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62548	Intranasal lacrimal electrical neurostimulator	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PQJ	Intranasal electrostimulation device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN160030	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6ef80d1b-815a-4f56-ac8e-c0db45927b87
Public Version Date: May 24, 2021
Public Version Number: 4
DI Record Publish Date: February 15, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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