HemoCue® Glucose 201 Microcuvettes 110706

GUDID 07311091107060

HemoCue Glucose 201 Microcuvettes 4x25 vial

Hemocue AB

Home-use/point-of-care blood glucose monitoring system IVD

• Primary Device ID: 07311091107060
• NIH Device Record Key: 8294182a-37d0-4fab-bffb-41d4b4228aea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemoCue® Glucose 201 Microcuvettes
• Version Model Number: 110706
• Catalog Number: 110706
• Company DUNS: 356164426
• Company Name: Hemocue AB
• Device Count: 25
• 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 unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07311091107060 [Package]; Contains: 17311091107067; Package: package [4 Units]; In Commercial Distribution
GS1	17311091107067 [Primary]
GS1	27311091107064 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020935

FDA Product Code

• CGA: Glucose Oxidase, Glucose

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: 2018-07-06
• Device Publish Date: 2016-05-31

On-Brand Devices [HemoCue® Glucose 201 Microcuvettes]

• 07311091107237: HemoCue Glucose 201 Microcuvettes 2x25 single
• 07311091107060: HemoCue Glucose 201 Microcuvettes 4x25 vial
• 07311091107053: HemoCue Glucose 201 Microcuvettes 4x25 single