MAXX

Basic Information

• Brand Name: MAXX
• Primary DI: 00850014593384
• Version / Model: MXCB
• Catalog Number: MXCB-1
• Company Name: ROYAL BIOLOGICS INC.
• Labeler DUNS: 080562141
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-12
• Public Version: 1
• Public Version Date: 2021-05-20
• Public Version Status: New
• Public Device Record Key: b31324bc-76c8-4897-93b1-a2f1baa2246f

Device Description

The Royal MAXX™ Accessory Kit is designed for use with the Royal MAXX™ PRP and BMC concentration systems. The kit contains 2 reuseable Royal MAXX Counterbalances and 2 reuseable Turn keys .

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	864.9245	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46923	Haematological concentrate system preparation kit, platelet concentration	A collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850014593381	GS1	case	20	In Commercial Distribution
Primary	00850014593384	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
BK210563	0

Device Sizes

Type	Value	Unit	Text
Total Volume	60	Milliliter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius