Miris Check™

Basic Information

• Brand Name: Miris Check™
• Primary DI: 07350107530027
• Version / Model: 39-01-003
• Catalog Number: 39-01-003
• 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: 7
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 8489436c-dba2-4154-8d70-0bb6a5d553d0

Device Description

Zero-setting solution for Miris Human Milk Analyzer™. Concentrate, 10 mL. Dilute the content with 90 mL distilled or deionized water and mix. Warm to 35-40° C before use.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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
58048	Optical laboratory instrument performance standard calibrator/control IVD, single-use	A reference standard solution or soluble substance of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical laboratory instrument (e.g., spectrophotometer, nephelometer, microplate reader, PCR instrument, flow cytometer). Verification/optimization functions may include optical density (absorbance/scattering), fluorescent/luminescent accuracy and compensation, linearity at specified wavelengths and/or stray light interference. It may be used to verify pipetting/dispensing/aspiration/diluting functions using spectrophotometry/nephelometry to determine concentration/residual volume. Solutions may be single or short-term use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350107530027	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN180007	000

Device Sizes

Type	Value	Unit	Text
Total Volume	10	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: dark
• Type: Storage Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius