Miris Human Milk Analyzer™

Primary DI: 17350107530079
Brand: Miris Human Milk Analyzer™
Company: Miris AB
Model: Miris HMA US
Catalog number: 08-02-107
Device description: 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. The Miris HMA is also intended for use by personnel trained in the use of the device at Human Milk Banking Association of North America (HMBANA) accredited human milk banks, for the purpose of labeling milk donations and in the processing of milk donations.
Published: 2019-04-23
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true

Contact Domains#

Code, Name table
Code	Name
QEI	Breast Milk Macronutrients Test System

Code, Device, Specialty table
Code	Device	Specialty	Class
QEI	Breast Milk Macronutrients Test System	Clinical Chemistry	2

Submission, Supplement table
Submission	Supplement
DEN180007	000
K223085	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
DEN180007	000	Miris Human Milk Analyzer	Miris AB	2018-12-21	QEI
K223085	000	Miris Human Milk Analyzer (HMA)	Miris AB	2023-09-29	QEI

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
27350107530076	Package	GS1	1	In Commercial Distribution
17350107530079	Primary	GS1	0

Source identifier, GTIN-14 normalized table
Source identifier	GTIN-14 normalized
27350107530076	27350107530076
17350107530079	17350107530079

Term, Definition table
Term	Definition
Breast milk analyser IVD	An electrically-powered device intended to be used for the quantitative determination of the nutritional content of a breast milk specimen, using infrared spectroscopy. The device is used to measure the concentration of fat, carbohydrate and protein, to aid healthcare professionals in the nutritional management of newborns and infants. It is a benchtop laboratory instrument with dedicated operational, data processing and/or data display software.

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

Phone, Email table
Phone	Email
+4618146907	support@mirissolutions.com

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
07350107530041	Miris Calibration Control Kit™	05-07-101	05-07-101	2022-05-04
07350107530027	Miris Check™	39-01-003	39-01-003	2019-04-23
07350107530034	Miris Cleaner™	39-04-001	39-04-001	2019-04-23
87350107530047	Miris Calibration Control Kit™	05-07-101	05-07-101	2022-05-04
27350107530076	Miris Human Milk Analyzer™	Miris HMA US	08-02-107	2019-04-23

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
07350107530027	Miris Check™	Miris AB	QEI	2019-04-23
07350107530034	Miris Cleaner™	Miris AB	QEI	2019-04-23
27350107530076	Miris Human Milk Analyzer™	Miris AB	QEI	2019-04-23