ScoutPro Osmolarity System

GUDID 10853539002185

In-vitro analysis of ocular tear fluid.

Tearlab Corporation

Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD

• Primary Device ID: 10853539002185
• NIH Device Record Key: 4009cb79-d026-46cd-a6f9-9de742172f92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScoutPro Osmolarity System
• Version Model Number: 100094
• Company DUNS: 155813749
• Company Name: Tearlab Corporation
• Device Count: 200
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853539002188 [Primary]
GS1	10853539002185 [Unit of Use]

FDA Product Code

• OND: Osmolality Of Tears

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: 2022-12-14
• Device Publish Date: 2022-12-06

Devices Manufactured by Tearlab Corporation

• 10853539002048 - Osmolarity Normal Control Solutions: 2024-01-15
• 10853539002055 - Osmolarity High Control Solution: 2024-01-15
• 10853539002185 - ScoutPro Osmolarity System: 2022-12-14In-vitro analysis of ocular tear fluid.
• 10853539002185 - ScoutPro Osmolarity System: 2022-12-14 In-vitro analysis of ocular tear fluid.