LIPIFLOW SYSTEM CONSOLE 210000

GUDID 00859623006414

ASSEMBLY PKGD LIPIFLOW - US

TEARSCIENCE, INC.

Eyelid thermal pulsation system control unit Eyelid thermal pulsation system control unit Eyelid thermal pulsation system control unit Eyelid thermal pulsation system control unit Eyelid thermal pulsation system control unit Eyelid thermal pulsation system control unit Eyelid thermal pulsation system control unit Eyelid thermal pulsation system control unit Eyelid thermal pulsation system control unit Eyelid thermal pulsation system control unit Eyelid thermal pulsation system control unit Eyelid thermal pulsation system control unit Eyelid thermal pulsation system control unit Eyelid thermal pulsation system control unit

• Primary Device ID: 00859623006414
• NIH Device Record Key: e7d681fd-96d8-45fd-b5fb-235fb99f7fec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIPIFLOW SYSTEM CONSOLE
• Version Model Number: LFTP-1000
• Catalog Number: 210000
• 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
• Phone: +1(877)266-4543
• Email: JJV-US-SurgicalOrders@its.jnj.com
• Phone: +1(877)266-4543
• Email: JJV-US-SurgicalOrders@its.jnj.com
• Phone: +1(877)266-4543
• Email: JJV-US-SurgicalOrders@its.jnj.com
• Phone: +1(877)266-4543
• Email: JJV-US-SurgicalOrders@its.jnj.com
• Phone: +1(877)266-4543
• Email: JJV-US-SurgicalOrders@its.jnj.com
• Phone: +1(877)266-4543
• Email: JJV-US-SurgicalOrders@its.jnj.com
• Phone: +1(877)266-4543
• Email: JJV-US-SurgicalOrders@its.jnj.com
• Phone: +1(877)266-4543
• Email: JJV-US-SurgicalOrders@its.jnj.com
• Phone: +1(877)266-4543
• Email: JJV-US-SurgicalOrders@its.jnj.com
• Phone: +1(877)266-4543
• Email: JJV-US-SurgicalOrders@its.jnj.com
• Phone: +1(877)266-4543
• Email: JJV-US-SurgicalOrders@its.jnj.com
• Phone: +1(877)266-4543
• Email: JJV-US-SurgicalOrders@its.jnj.com
• Phone: +1(877)266-4543
• Email: JJV-US-SurgicalOrders@its.jnj.com

Device Dimensions

• Pressure: 6 Pound per Square Inch
• Pressure: 6 Pound per Square Inch
• Pressure: 6 Pound per Square Inch
• Pressure: 6 Pound per Square Inch
• Pressure: 6 Pound per Square Inch
• Pressure: 6 Pound per Square Inch
• Pressure: 6 Pound per Square Inch
• Pressure: 6 Pound per Square Inch
• Pressure: 6 Pound per Square Inch
• Pressure: 6 Pound per Square Inch
• Pressure: 6 Pound per Square Inch
• Pressure: 6 Pound per Square Inch
• Pressure: 6 Pound per Square Inch
• Pressure: 6 Pound per Square Inch

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859623006414 [Primary]

FDA Product Code

• ORZ: Eyelid thermal pulsation system

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

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• 00859623006414 - LIPIFLOW SYSTEM CONSOLE: 2019-10-04ASSEMBLY PKGD LIPIFLOW - US
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• 00859623006612 - LIPIVIEW II OCULAR SURFACE INTERFEROMETE: 2019-10-04 ASSEMBLY PKGD LIPIVIEW-2 - US