FDA UDI
In Commercial Distribution
🇺🇸 United States
Miris Human Milk Analyzer™
DI: 17350107530079
·
Model: Miris HMA US
·
Miris AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Miris Human Milk Analyzer™
- Primary DI
- 17350107530079
- Version / Model
- Miris HMA US
- Catalog Number
- 08-02-107
- Company Name
- Miris AB
- Labeler DUNS
- 632704677
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-23
- Public Version
- 3
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 22ce1df1-a1db-4d29-bdf5-f124d21868e3
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QEI | Breast Milk Macronutrients Test System | Clinical Chemistry | 862.1493 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64231 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 27350107530076 | GS1 | box | 1 | In Commercial Distribution | |
| Primary | 17350107530079 | GS1 |
Customer Contacts
- Phone
- +4618146907
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- freight, empty cuvette: between 0 and 50 Degrees Celcius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 600 – 1100 millibar
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 20 – 30 Degrees Celsius