AVAmax

Basic Information

• Brand Name: AVAmax
• Primary DI: 10885403002120
• Version / Model: VMXXLCT
• Catalog Number: VMXXLCT
• Company Name: CAREFUSION 2200, INC
• Labeler DUNS: 832696038
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-12
• Public Version: 3
• Public Version Date: 2019-11-12
• Public Version Status: Update
• Public Device Record Key: def836d0-04b5-4542-a57f-6b74c90d9c83
• Distribution End Date: 2017-12-31

Device Description

AVAmax PLUS Extra Level Tray Bone Cement Delivery System

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: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDN	Cement, Bone, Vertebroplasty	Orthopedic	888.3027	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45253	Orthopaedic cement preparation/delivery kit	A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885403002128	GS1	Case	5	Not in Commercial Distribution	2017-12-31
Primary	10885403002120	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Flash Point 50°F (10°C). Keep away from heat, sparks, open flame, and other sources of ignition. Store in a dark, dry place below 77°F (25°C) and protect from light.