LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)

Basic Information

• Brand Name: LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)
• Primary DI: 00859623006216
• Version / Model: LFD-1100
• Catalog Number: 221001
• Company Name: TEARSCIENCE, INC.
• Labeler DUNS: 791626901
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 8
• Public Version Date: 2023-05-22
• Public Version Status: Update
• Public Device Record Key: 1c6c6dac-5994-4a8b-9194-c14d170f7b26
• Distribution End Date: 2023-03-15

Device Description

ACTIVATORS (BOX OF 10) US

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ORZ	Eyelid thermal pulsation system	Ophthalmic	886.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58218	Eyelid thermal pulsation system applicator	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859623006216	GS1
Package	20859623006234	GS1	BOX	10	Not in Commercial Distribution	2023-03-15

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Pressure	6	Pound per Square Inch

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius