SmartMix Vacuum Footpump and Airhose

Basic Information

• Brand Name: SmartMix Vacuum Footpump and Airhose
• Primary DI: 15060238200148
• Version / Model: 5401-96-500
• Company Name: SUMMIT MEDICAL LIMITED
• Labeler DUNS: 221751311
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-09
• Public Version: 1
• Public Version Date: 2023-02-17
• Public Version Status: New
• Public Device Record Key: 96c58fc5-0c17-4f17-a25e-5c413efca195

Device Description

SmartMix Vacuum Footpump and Airhose

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
JDY	Evacuator, Vapor, Cement Monomer	Orthopedic	888.4220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60520	Orthopaedic material preparation vacuum pump	A pneumatically-powered device intended to create negative pressure (vacuum) during orthopaedic cement/filler mixing to help improve the quality of the resulting cement/filler (e.g., reduced porosity and fatigue). It is typically a portable unit containing a pump with a pressure dial/display and control(s), and is usually used in conjunction with an orthopaedic cement-mixing container and fume evacuation/filtering devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060238200148	GS1

Customer Contacts

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