FDA.reportPublic FDA data

Miris Human Milk Analyzer™

Primary DI
27350107530076
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.
Published
2019-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QEIBreast Milk Macronutrients Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEIBreast Milk Macronutrients Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN180007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN180007000Miris Human Milk AnalyzerMiris AB2018-12-21QEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27350107530076PackageGS11In Commercial Distribution
17350107530079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2735010753007627350107530076
1735010753007917350107530079

GMDN Terms#

Term, Definition table
TermDefinition
Breast milk analyser IVDAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure600 millibar1100 millibar
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature20 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00freight, empty cuvette: between 0 and 50 Degrees Celcius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
632704677
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17350107530079Miris Human Milk Analyzer™Miris HMA US08-02-1072019-04-23
07350107530041Miris Calibration Control Kit™05-07-10105-07-1012022-05-04
07350107530027Miris Check™39-01-003 39-01-003 2019-04-23
07350107530034Miris Cleaner™39-04-001 39-04-001 2019-04-23
87350107530047Miris Calibration Control Kit™05-07-10105-07-1012022-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17350107530079Miris Human Milk Analyzer™Miris ABQEI2019-04-23
07350107530027Miris Check™Miris ABQEI2019-04-23
07350107530034Miris Cleaner™Miris ABQEI2019-04-23