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 Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use
Primary Device ID07350107530027
NIH Device Record Key8489436c-dba2-4154-8d70-0bb6a5d553d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiris Check™
Version Model Number39-01-003
Catalog Number39-01-003
Company DUNS632704677
Company NameMiris AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com
Phone+4618146907
Emailsupport@mirissolutions.com

Device Dimensions

Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
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Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
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Total Volume10 Milliliter
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Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *dark
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107350107530027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEIBreast Milk Macronutrients Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-06-23
Device Publish Date2019-04-23

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

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