HemoCue® Albumin 201 Analyzer 120623

GUDID 07311091206237

HemoCue Albumin 201 Analyzer mg/L

Hemocue AB

Urine analyser IVD, point-of-care

• Primary Device ID: 07311091206237
• NIH Device Record Key: e78eba27-1836-4512-bef9-be4294cff29d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemoCue® Albumin 201 Analyzer
• Version Model Number: 120623
• Catalog Number: 120623
• Company DUNS: 356164426
• Company Name: Hemocue AB
• 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 Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07311091206237 [Primary]

FDA Product Code

• KQO: Automated Urinalysis System

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: 2019-05-03
• Device Publish Date: 2019-04-25

Devices Manufactured by Hemocue AB

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• 07311091218278 - HemoCue® Hb301 Analyzer: 2020-09-14 HemoCue Hb301 Analyzer g/dL
• 07311091118097 - HemoCue® Hb 301 Microcuvettes: 2020-09-14 HemoCue Hb 301 Microcuvettes 4x50 vial
• 07311091391681 - HemoCue® 801 Connect: 2019-07-02 HemoCue® 801 Connect
• 07311091206237 - HemoCue® Albumin 201 Analyzer: 2019-05-03HemoCue Albumin 201 Analyzer mg/L
• 07311091206237 - HemoCue® Albumin 201 Analyzer: 2019-05-03 HemoCue Albumin 201 Analyzer mg/L
• 17311091106084 - HemoCue® Urine Albumin Microcuvettes: 2019-05-03 HemoCue Urine Albumin Microcuvettes 2x25 single
• 17311091119022 - HemoCue® Hb 801 Microcuvettes: 2019-03-11 HemoCue Hb 801 Microcuvettes 4x50 vial