HemoCue® WBC Microcuvettes 113003

GUDID 07311091130037

HemoCue WBC Microcuvettes 4x40 vial

Hemocue AB

Haematological cell analyser IVD, semi-automated Haematological cell analyser IVD, semi-automated Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD

• Primary Device ID: 07311091130037
• NIH Device Record Key: 5e4f08b4-668e-4669-9c61-c5be02afa6ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemoCue® WBC Microcuvettes
• Version Model Number: 113003
• Catalog Number: 113003
• Company DUNS: 356164426
• Company Name: Hemocue AB
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C,
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07311091130037 [Package]; Contains: 17311091130034; Package: package [4 Units]; In Commercial Distribution
GS1	17311091130034 [Primary]
GS1	27311091130031 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071652

FDA Product Code

• GKL: Counter, Cell, Automated (Particle 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-05-31

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