HemoCue® Hb 301 Microcuvettes 111814

GUDID 27311091118077

HemoCue Hb 301 Microcuvettes 4x75 vial

Hemocue AB

Haemoglobin analyser IVD, point-of-care

• Primary Device ID: 27311091118077
• NIH Device Record Key: 53bc9fd3-2158-4f77-98bd-2c0399137c1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemoCue® Hb 301 Microcuvettes
• Version Model Number: 111814
• Catalog Number: 111814
• Company DUNS: 356164426
• Company Name: Hemocue AB
• Device Count: 75
• 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 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	17311091118148 [Primary]
GS1	27311091118077 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• BK060048

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: 1
• Public Version Date: 2022-11-07
• Device Publish Date: 2022-10-28

On-Brand Devices [HemoCue® Hb 301 Microcuvettes]

• 07311091118073: HemoCue Hb 301 Microcuvettes 4x75 vial
• 07311091118011: HemoCue Hb 301 Microcuvettes 4x50 vial
• 07311091118097: HemoCue Hb 301 Microcuvettes 4x50 vial
• 27311091118121: HemoCue Hb 301 Microcuvettes 4x50 vial
• 27311091118077: HemoCue Hb 301 Microcuvettes 4x75 vial