UltraMIST Generator CP-80031

GUDID 00816789010211

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.

ALLIQUA BIOMEDICAL, INC.

Wound therapy ultrasound system generator

• Primary Device ID: 00816789010211
• NIH Device Record Key: d0279ca9-65ed-4a6f-adab-6b92373e6672
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraMIST Generator
• Version Model Number: CP-80031
• Catalog Number: CP-80031
• Company DUNS: 872967679
• Company Name: ALLIQUA BIOMEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 844-963-2273
• Email: MIST.CS@Alliqua.com
• Phone: 844-963-2273
• Email: MIST.CS@Alliqua.com
• Phone: 844-963-2273
• Email: MIST.CS@Alliqua.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816789010211 [Primary]
GS1	10816789010218 [Package]; Package: Corrugated Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140782

FDA Product Code

• NRB: Wound Cleaner, Ultrasound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-07

Devices Manufactured by ALLIQUA BIOMEDICAL, INC.

• 10816789010201 - UltraMIST Treatment Wand: 2018-07-06 A hand-held mains electricity electronic component of a wound therapy ultrasound system intended to convert (transduce) electric
• 00816789010211 - UltraMIST Generator: 2018-07-06A 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.
• 00816789010211 - UltraMIST Generator: 2018-07-06 A portable assembly of mains electricity devices intended to deliver low frequency ultrasound energy via a fluid mist to a wound
• 20816789010239 - UltraMIST Applicator: 2018-07-06 A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low f
• 20816789010246 - MIST 360 Applicator: 2018-07-06 A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low f
• 20816789010253 - MIST Therapy Applicator: 2018-07-06 A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low f