HemoCue® Hb 201 Microcuvettes 111731

GUDID 07311091117311

HemoCue Hb 201 Microcuvettes 4x50 vial

Hemocue AB

Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care

• Primary Device ID: 07311091117311
• NIH Device Record Key: d58bdcf8-0c46-4605-b874-3b9d83633f3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemoCue® Hb 201 Microcuvettes
• Version Model Number: 111731
• Catalog Number: 111731
• Company DUNS: 356164426
• Company Name: Hemocue AB
• Device Count: 50
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07311091117311 [Package]; Contains: 17311091117318; Package: Package [4 Units]; In Commercial Distribution
GS1	17311091117318 [Primary]
GS1	27311091117315 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032203

FDA Product Code

• GKR: System, Hemoglobin, Automated

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-25

On-Brand Devices [HemoCue® Hb 201 Microcuvettes]

• 07311091117328: HemoCue Hb 201 Microcuvettes 4x25 single
• 07311091117311: HemoCue Hb 201 Microcuvettes 4x50 vial
• 07311091117168: HemoCue Hb 201 Microcuvettes 4x50 vial
• 07311091117151: HemoCue Hb 201 Microcuvettes 4x25 single