AccessGUDID - DEVICE: LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE (00859623006315)

GUDID

Device Identifier (DI) Information

Brand Name: LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE
Version or Model: LFD-2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 221050
Company Name: TEARSCIENCE, INC.

Primary DI Number: 00859623006315
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791626901 *Terms of Use

Device Description: ACTIVATORS (BOX OF 10) US

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:	Yes
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?
58218	Eyelid thermal pulsation system applicator, single-use	An ophthalmic device designed to apply heat and pressure (intermittent pressure massage) to the outer eyelid surface for treatment of lid margin disease (LMD), meibomian gland dysfunction (MGD) and/or evaporative dry eye. It consists of two small plates, one positioned under the eyelid, and the other with heating/pulsing elements applied to the outside of the eyelid, and is used with a reusable control unit (not included). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ORZ	Eyelid thermal pulsation system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Pressure: 6 Pound per Square Inch

Device Record Status

Public Device Record Key: 09a06cf3-bc19-42bb-9c4f-7e790857caa3
Public Version Date: January 20, 2025
Public Version Number: 8
DI Record Publish Date: December 24, 2016