TearCheck T

GUDID 03662824001846

E-SWIN

Corneal topography system analyser

• Primary Device ID: 03662824001846
• NIH Device Record Key: 2360964a-4f5f-4cb5-a5e8-7b49c6193d4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TearCheck T
• Version Model Number: V040US000A08A
• Company DUNS: 267700713
• Company Name: E-SWIN
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662824001846 [Primary]

FDA Product Code

• MMQ: Topographer, Corneal, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-14
• Device Publish Date: 2023-03-06

On-Brand Devices [TearCheck T]

• 03662824003048: N040US000A08A
• 03662824001846: V040US000A08A