TearCheck T

GUDID 03662824003048

E-SWIN

Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser

• Primary Device ID: 03662824003048
• NIH Device Record Key: e06bd019-e0bc-4ce7-8d6e-664736e69097
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TearCheck T
• Version Model Number: N040US000A08A
• 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	03662824003048 [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