Osmolarity Normal Control Solutions

GUDID 10853539002048

Tearlab Corporation

Osmolality IVD, control Osmolality IVD, control Osmolality IVD, control Osmolality IVD, control Osmolality IVD, control Osmolality IVD, control Osmolality IVD, control Osmolality IVD, control Osmolality IVD, control Osmolality IVD, control Osmolality IVD, control Osmolality IVD, control Osmolality IVD, control Osmolality IVD, control Osmolality IVD, control

• Primary Device ID: 10853539002048
• NIH Device Record Key: 667cca4b-a42d-4bf8-b25f-3dd5e3b37c04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osmolarity Normal Control Solutions
• Version Model Number: 100012
• 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	00853539002041 [Primary]
GS1	10853539002048 [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
• 10853539002048 - Osmolarity Normal Control Solutions: 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.