Boule EasyCleaner 1504513

GUDID 07350040791417

Boule EasyCleaner is an accessory intended for regular cleaning and maintenance of Medonic M51/Swelab Lumi inlet and fluidic system

Boule Medical AB

Full blood count IVD, reagent

• Primary Device ID: 07350040791417
• NIH Device Record Key: 4e7ac831-eb2c-4608-bb4b-c17365e7d38d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Boule EasyCleaner
• Version Model Number: Boule EasyCleaner, 50ml
• Catalog Number: 1504513
• Company DUNS: 354417933
• Company Name: Boule Medical AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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: 1800-453-3328
• Email: qualitygroup@boule.com
• Phone: 1800-453-3328
• Email: qualitygroup@boule.com
• Phone: 1800-453-3328
• Email: qualitygroup@boule.com
• Phone: 1800-453-3328
• Email: qualitygroup@boule.com
• Phone: 1800-453-3328
• Email: qualitygroup@boule.com
• Phone: 1800-453-3328
• Email: qualitygroup@boule.com
• Phone: 1800-453-3328
• Email: qualitygroup@boule.com
• Phone: 1800-453-3328
• Email: qualitygroup@boule.com
• Phone: 1800-453-3328
• Email: qualitygroup@boule.com
• Phone: 1800-453-3328
• Email: qualitygroup@boule.com
• Phone: 1800-453-3328
• Email: qualitygroup@boule.com
• Phone: 1800-453-3328
• Email: qualitygroup@boule.com
• Phone: 1800-453-3328
• Email: qualitygroup@boule.com
• Phone: 1800-453-3328
• Email: qualitygroup@boule.com
• Phone: 1800-453-3328
• Email: qualitygroup@boule.com
• Phone: 1800-453-3328
• Email: qualitygroup@boule.com
• Phone: 1800-453-3328
• Email: qualitygroup@boule.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350040791417 [Primary]

FDA Product Code

• JCB: Detergent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-14
• Device Publish Date: 2024-10-04

Devices Manufactured by Boule Medical AB

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• 07350040791417 - Boule EasyCleaner: 2024-10-14Boule EasyCleaner is an accessory intended for regular cleaning and maintenance of Medonic M51/Swelab Lumi inlet and fluidic system
• 07350040791417 - Boule EasyCleaner: 2024-10-14 Boule EasyCleaner is an accessory intended for regular cleaning and maintenance of Medonic M51/Swelab Lumi inlet and fluidic sys
• 07350040796399 - Medonic M51-D Diluent: 2024-10-14 The reagents are accessories intended to be used in combination with the Medonic M51. The diluent dilutes the blood sample to en
• 07350040796405 - Medonic M51-L1 Lyse: 2024-10-14 The reagents are accessories intended to be used in combination with the Medonic M51. The lyse reagents lyses the red blood cell
• 07350040796412 - Medonic M51-L2 Lyse: 2024-10-14 The reagents are accessories intended to be used in combination with the Medonic M51. The lyse reagents lyses the red blood cell
• 07350040796429 - Swelab Lumi-D Diluent: 2024-10-14 The reagents are accessories intended to be used in combination with the Swelab Lumi. The diluent dilutes the blood sample to en
• 07350040796436 - Swelab Lumi-L1 Lyse: 2024-10-14 The reagents are accessories intended to be used in combination with the Swelab Lumi analyzer. The lyse reagents lyses the red b
• 07350040796443 - Swelab Lumi-L2 Lyse: 2024-10-14 The reagents are accessories intended to be used in combination with the Swelab Lumi analyzer. The lyse reagents lyses the red b