Medonic M-series 1400075

GUDID 07350040796375

A fully automatic, 3-part differential, hematology analyzer intended for in vitro diagnostic testing of blood specimens under laboratory conditions.

Boule Medical AB

Haematological cell analyser IVD, automated

• Primary Device ID: 07350040796375
• NIH Device Record Key: 63f4ad48-6372-487e-822c-6f8460bc4636
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medonic M-series
• Version Model Number: M16S BD ABR US
• Catalog Number: 1400075
• Company DUNS: 354417933
• Company Name: Boule Medical 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com
• Phone: 1800-453-3328
• Email: quality@cdsolink.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350040796375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083420

FDA Product Code

• GKZ: Counter, Differential Cell

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-09-17

On-Brand Devices [Medonic M-series]

• 07350040796375: A fully automatic, 3-part differential, hematology analyzer intended for in vitro diagnostic tes
• 07350040796368: A fully automatic, 3-part differential, hematology analyzer intended for in vitro diagnostic tes
• 07350040796351: A fully automatic, 3-part differential, hematology analyzer intended for in vitro diagnostic tes
• 07350040796344: A fully automatic, 3-part differential, hematology analyzer intended for in vitro diagnostic tes