Miris Cleaner™ 39-04-001

GUDID 07350107530034

Cleaning agent for Miris Human Milk Analyzer™. Concentrate, 50 mL. Dilute the content with 950 mL distilled or deionized water and mix. Warm to 40°C before use.

Miris AB

Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment Wash/cleaning solution IVD, manual equipment
Primary Device ID07350107530034
NIH Device Record Key02a8a3cc-e121-4a98-8995-439e46cd51ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiris Cleaner™
Version Model Number39-04-001
Catalog Number39-04-001
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
Phone+4618146907
Emailsupport@mirissolutions.com

Device Dimensions

Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
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Total Volume50 Milliliter
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Total Volume50 Milliliter
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Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 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 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *out of direct sunlight
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107350107530034 [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™2020-06-23 Zero-setting solution for Miris Human Milk Analyzer™. Concentrate, 10 mL. Dilute the content with 90 mL distilled or deionize
07350107530034 - Miris Cleaner™2020-06-23Cleaning agent for Miris Human Milk Analyzer™. Concentrate, 50 mL. Dilute the content with 950 mL distilled or deionized water and mix. Warm to 40°C before use.
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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