HemoCue® Hb 801 Microcuvettes 111902

GUDID 17311091119022

HemoCue Hb 801 Microcuvettes 4x50 vial

Hemocue AB

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

• Primary Device ID: 17311091119022
• NIH Device Record Key: 61488628-1640-4042-85a3-376269f05f57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemoCue® Hb 801 Microcuvettes
• Version Model Number: 111902
• Catalog Number: 111902
• 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

• 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 *Microcuvettes in the vial (opened or unopened) 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 *Microcuvettes in the vial (opened or unopened) can be stored for a shorter period of time (6 weeks) between -18–50 °C (0–122 °F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	07311091119025 [Package]; Package: Package [4 Units]; In Commercial Distribution
GS1	17311091119022 [Primary]
GS1	27311091119029 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181751

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: 2019-03-11
• Device Publish Date: 2019-02-06

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: 2019-05-03 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: 2019-03-11HemoCue Hb 801 Microcuvettes 4x50 vial
• 17311091119022 - HemoCue® Hb 801 Microcuvettes: 2019-03-11 HemoCue Hb 801 Microcuvettes 4x50 vial