Miris Check™ 39-01-003

GUDID 07350107530027

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 40° C before use.

Miris AB

Optical instrument calibration/verification solution IVD

• Primary Device ID: 07350107530027
• NIH Device Record Key: 8489436c-dba2-4154-8d70-0bb6a5d553d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miris Check™
• Version Model Number: 39-01-003
• Catalog Number: 39-01-003
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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
• 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

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
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• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *dark
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350107530027 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-06-23
• 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™: 2020-06-23Zero-setting solution for Miris Human Milk Analyzer™. Concentrate, 10 mL. Dilute the content with 90 mL distilled or deionized water and mix. Warm to 40° C before use.
• 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™: 2019-05-01 The Miris Human Milk Analyzer (HMA) quantitatively measures the concentration of fat, protein, and carbohydrate in human milk. T