HemoCue® Plasma/Low Hb Microcuvettes 110302

GUDID 07311091103024

HemoCue Plasma/Low Hb Microcuvettes 4x25 vial

Hemocue AB

Haemoglobin analyser IVD, point-of-care

• Primary Device ID: 07311091103024
• NIH Device Record Key: 9669ec20-4946-4ecf-8938-b78cb9b4e1ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemoCue® Plasma/Low Hb Microcuvettes
• Version Model Number: 110302
• Catalog Number: 110302
• 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 *Do not refrigerate
• 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 *Do not refrigerate
• 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	07311091103024 [Package]; Contains: 17311091103021; Package: package [4 Units]; In Commercial Distribution
GS1	17311091103021 [Primary]
GS1	27311091103028 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• BK000043

FDA Product Code

• GKR: System, Hemoglobin, Automated

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: 2016-05-27

Devices Manufactured by Hemocue AB

• 27311091118077 - HemoCue® Hb 301 Microcuvettes: 2022-11-07 HemoCue Hb 301 Microcuvettes 4x75 vial
• 27311091118121 - HemoCue® Hb 301 Microcuvettes: 2022-09-07 HemoCue Hb 301 Microcuvettes 4x50 vial
• 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: 2019-03-11 HemoCue Hb 801 Microcuvettes 4x50 vial