Osmolarity High Control Solution

GUDID 10853539002055

Tearlab Corporation

Osmolality IVD, control

• Primary Device ID: 10853539002055
• NIH Device Record Key: 8768574d-629c-480b-8ace-736bbda37b97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osmolarity High Control Solution
• Version Model Number: 100013
• Company DUNS: 155813749
• Company Name: Tearlab Corporation
• Device Count: 500
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853539002058 [Primary]
GS1	10853539002055 [Unit of Use]

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: 2024-01-15
• Device Publish Date: 2024-01-05

Devices Manufactured by Tearlab Corporation

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