UltraMIST Generator

Basic Information

• Brand Name: UltraMIST Generator
• Primary DI: 00816789010211
• Version / Model: CP-80031
• Catalog Number: CP-80031
• Company Name: ALLIQUA BIOMEDICAL, INC.
• Labeler DUNS: 872967679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d0279ca9-65ed-4a6f-adab-6b92373e6672

Device Description

A portable assembly of mains electricity devices intended to deliver low frequency ultrasound energy via a fluid mist to a wound to promote healing of the wound without direct wound contact. The generator generates radio-frequency electrical energy which is subsequently transduced into ultrasound energy in the system treatment wand and pumps a fluid solution for the production of an ultrasound-conductive mist used to promote wound healing. The generator is intended to be used in conjunction with a system treatment wand and fluid source such as saline.

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
NRB	Wound Cleaner, Ultrasound	General, Plastic Surgery	878.4410	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62139	Wound therapy ultrasound system generator	A mains electricity (AC-powered) component of a wound therapy ultrasound (US) system intended to generate radio-frequency (RF) electrical energy, subsequently transduced into US energy in the system handpiece, and to pump a fluid solution for the production of an ultrasound-conductive mist used to promote wound healing through cleansing and debridement. It is intended to be used in conjunction with a system handpiece/tip, and fluid source (e.g., saline).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816789010211	GS1
Package	10816789010218	GS1	Corrugated Carton	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K140782	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius