LIPIFLOW SYSTEM CONSOLE 210000

GUDID 00859623006414

ASSEMBLY PKGD LIPIFLOW - US

TEARSCIENCE, INC.

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