LIPIVIEW II OCULAR SURFACE INTERFEROMETE 100100

GUDID 00859623006612

ASSEMBLY PKGD LIPIVIEW-2 - US

TEARSCIENCE, INC.

Meibomian gland camera/ophthalmic interferometer

• Primary Device ID: 00859623006612
• NIH Device Record Key: 8480b5e2-ece7-4e09-84dd-77df689ff977
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIPIVIEW II OCULAR SURFACE INTERFEROMETE
• Version Model Number: LVI-2000
• Catalog Number: 100100
• 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 5 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859623006612 [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

Devices Manufactured by TEARSCIENCE, INC.

• 00859623006001 - MEIBOMIAN GLAND EVALUATOR: 2020-03-05 MEIBOMIAN GLAND EVALUATOR - GBL
• 00859623006018 - MEIBOMIAN GLAND EVALUATOR: 2020-03-05 MEIBOMIAN GLAND EVALUATOR - AU,CA,US
• 20859623006135 - LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE): 2020-03-05 ACTIVATORS (BOX OF 10) US
• 00859623006216 - LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE): 2020-03-05 ACTIVATORS (BOX OF 10) US
• 20859623006333 - LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE: 2020-03-05 ACTIVATORS (BOX OF 10) US
• 00859623006414 - LIPIFLOW SYSTEM CONSOLE: 2019-10-04 ASSEMBLY PKGD LIPIFLOW - US
• 00859623006513 - LIPIVIEW OCULAR SURFACE INTERFEROMETER: 2019-10-04 ASSEMBLY PKGD LIPIVIEW 1 - INTL
• 00859623006612 - LIPIVIEW II OCULAR SURFACE INTERFEROMETE: 2019-10-04ASSEMBLY PKGD LIPIVIEW-2 - US
• 00859623006612 - LIPIVIEW II OCULAR SURFACE INTERFEROMETE: 2019-10-04 ASSEMBLY PKGD LIPIVIEW-2 - US