MEIBOMIAN GLAND EVALUATOR 400000

GUDID 00859623006919

ASSEMBLY PKGD LIPISCAN - US

TEARSCIENCE, INC.

Meibomian gland camera

• Primary Device ID: 00859623006919
• NIH Device Record Key: e51828f8-7e00-4277-9738-a6ba2031a567
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEIBOMIAN GLAND EVALUATOR
• Version Model Number: DMI-1000
• Catalog Number: 400000
• Company DUNS: 791626901
• Company Name: TEARSCIENCE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)266-4543
• Email: JJV-US-SurgicalOrders@its.jnj.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859623006919 [Primary]

FDA Product Code

• HKI: Camera, ophthalmic, ac-powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-04
• Device Publish Date: 2016-09-23

On-Brand Devices [MEIBOMIAN GLAND EVALUATOR]

• 00859623006919: ASSEMBLY PKGD LIPISCAN - US
• 00859623006018: MEIBOMIAN GLAND EVALUATOR - AU,CA,US
• 00859623006001: MEIBOMIAN GLAND EVALUATOR - GBL