MIST Therapy Applicator

Basic Information

• Brand Name: MIST Therapy Applicator
• Primary DI: 00816789010259
• Version / Model: CP-80011
• Catalog Number: CP-80011
• 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: dc457ca1-9f2f-42e4-82e2-e97939077774

Device Description

A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low frequency ultrasound energy from the treatment wand with a fluid solution (e.g., saline) for the production of an ultrasound-conductive mist used to promote wound healing. This is a single-use device.

Device Characteristics

• Single Use: Yes
• 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: 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: Yes
• Sterilization Methods: Radiation Sterilization

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
62141	Wound therapy ultrasound system handpiece tip	A sterile component of a wound therapy ultrasound (US) system intended to be attached to the system handpiece to interface low frequency US energy from the handpiece with a fluid solution (e.g., saline) for the production of an ultrasound-conductive mist used to promote wound healing. It typically includes fluid delivery tubing and is intended to fit on the distal end of the handpiece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20816789010253	GS1	Corrugated carton	6	In Commercial Distribution
Package	10816789010256	GS1	Kit tray	1	In Commercial Distribution
Primary	00816789010259	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K050129	000

Storage Conditions

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