LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE) 221000

GUDID 20859623006135

ACTIVATORS (BOX OF 10) US

TEARSCIENCE, INC.

Eyelid thermal pulsation system applicator

• Primary Device ID: 20859623006135
• NIH Device Record Key: 607234de-55d5-4a62-8662-a4ed426709dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)
• Version Model Number: LFD-1000
• Catalog Number: 221000
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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
• 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
• 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 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859623006117 [Primary]
GS1	20859623006135 [Package]; Contains: 00859623006117; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• ORZ: Eyelid thermal pulsation system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2020-03-05
• Device Publish Date: 2016-09-23

On-Brand Devices [LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)]

• 00859623006216: ACTIVATORS (BOX OF 10) US
• 20859623006135: ACTIVATORS (BOX OF 10) US