GUDID 10815845020222

ALERE SAN DIEGO, INC.

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• Primary Device ID: 10815845020222
• NIH Device Record Key: 21aa8043-efe8-4f10-b1ba-b46f6dfe00e3
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DMO-102
• Company DUNS: 194854949
• Company Name: ALERE SAN DIEGO, INC.
• Device Count: 40
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815845020225 [Unit of Use]
GS1	10815845020222 [Primary]

FDA Product Code

• NGL: Test, Opiates, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-05-24
• Device Publish Date: 2016-09-24

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• 00893038002937 - Cholestech LDX™: 2023-12-28 Cholestech LDX™ Lipid Profile GLU