Miris Human Milk Analyzer™ 08-02-107

GUDID 27350107530076

The Miris Human Milk Analyzer (HMA) quantitatively measures the concentration of fat, protein, and carbohydrate in human milk. The Miris HMA also provides calculated values for total solids and energy. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of newborns, including preterm, and infants. This device is intended for use in healthcare by trained healthcare personnel at clinical laboratories.

Miris AB

Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD Breast milk analyser IVD

• Primary Device ID: 27350107530076
• NIH Device Record Key: 22ce1df1-a1db-4d29-bdf5-f124d21868e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miris Human Milk Analyzer™
• Version Model Number: Miris HMA US
• Catalog Number: 08-02-107
• Company DUNS: 632704677
• Company Name: Miris AB
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com
• Phone: +4618146907
• Email: support@mirissolutions.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *freight, empty cuvette: between 0 and 50 Degrees Celcius
• Handling Environment Atmospheric Pressure: Between 600 millibar and 1100 millibar
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	17350107530079 [Primary]
GS1	27350107530076 [Package]; Contains: 17350107530079; Package: box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN180007

FDA Product Code

• QEI: Breast Milk Macronutrients Test System

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: 2019-05-01
• Device Publish Date: 2019-04-23

Devices Manufactured by Miris AB

• 87350107530047 - Miris Calibration Control Kit™: 2022-05-12 Quality control material for the Miris Human Milk Analyzer™. Miris Calibration Control Kit™ includes standardised solutions
• 07350107530027 - Miris Check™: 2020-06-23 Zero-setting solution for Miris Human Milk Analyzer™. Concentrate, 10 mL. Dilute the content with 90 mL distilled or deionize
• 07350107530034 - Miris Cleaner™: 2020-06-23 Cleaning agent for Miris Human Milk Analyzer™. Concentrate, 50 mL. Dilute the content with 950 mL distilled or deionized water
• 27350107530076 - Miris Human Milk Analyzer™: 2019-05-01The Miris Human Milk Analyzer (HMA) quantitatively measures the concentration of fat, protein, and carbohydrate in human milk. The Miris HMA also provides calculated values for total solids and energy. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of newborns, including preterm, and infants. This device is intended for use in healthcare by trained healthcare personnel at clinical laboratories.
• 27350107530076 - Miris Human Milk Analyzer™: 2019-05-01 The Miris Human Milk Analyzer (HMA) quantitatively measures the concentration of fat, protein, and carbohydrate in human milk. T