MAXX BMC MXBMC-60

GUDID 00850014593391

The Royal MAXX™ BMC concentration system is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of a mixture of peripheral blood and bone marrow aspirate at the patient’s point of care for mixing with autograft and/or allograft bone to improve handling characteristics. The system consists of a kit of consumables including a concentration device, syringes, blunt needle, alcohol wipes, ACD-A anticoagulant, and bone marrow aspiration supplies.

ROYAL BIOLOGICS INC.

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: 00850014593391
• NIH Device Record Key: f4c4917c-71df-4321-a215-d286e7ae9cdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAXX BMC
• Version Model Number: MXBMC-60
• Catalog Number: MXBMC-60
• Company DUNS: 080562141
• Company Name: ROYAL BIOLOGICS INC.
• 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: true
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com
• Phone: +1 201-488-1549
• Email: support@royalbiologics.com

Device Dimensions

• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014593391 [Primary]
GS1	10850014593398 [Package]; Package: case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK210632

FDA Product Code

• ORG: Platelet And Plasma Separator For Bone Graft Handling

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-13
• Device Publish Date: 2022-06-03

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• 00850014593650 - Bio-Reign 3D: 2023-02-20 Bio-Reign 3D Granules 5cc
• 00850014593667 - Bio-Reign 3D: 2023-02-20 Bio-Reign 3D Granules 10cc