UltraMIST Treatment Wand CP-80033

GUDID 10816789010201

A hand-held mains electricity electronic component of a wound therapy ultrasound system intended to convert (transduce) electrical energy into low frequency ultrasound energy for application to a wound site via a fluid mist to promote wound healing. It is a non-contact device which may include a display / controls, intended to connect proximally to the system generator and distally to a disposable applicator. It is used in conjunction with a fluid source such as saline with the ultrasound-conductive mist directed at the wound site for removal of fibrin, yellow slough, tissue exudates, and bacteria.

ALLIQUA BIOMEDICAL, INC.

Wound therapy ultrasound system handpiece
Primary Device ID10816789010201
NIH Device Record Key7a4eada4-22bd-439f-86af-27a32c118613
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraMIST Treatment Wand
Version Model NumberCP-80033
Catalog NumberCP-80033
Company DUNS872967679
Company NameALLIQUA BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-963-2273
EmailMIST.CS@Alliqua.com
Phone844-963-2273
EmailMIST.CS@Alliqua.com
Phone844-963-2273
EmailMIST.CS@Alliqua.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816789010204 [Primary]
GS110816789010201 [Package]
Contains: 00816789010204
Package: Corrugated carton [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRBWound Cleaner, Ultrasound

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-07

Devices Manufactured by ALLIQUA BIOMEDICAL, INC.

10816789010201 - UltraMIST Treatment Wand2018-07-06A hand-held mains electricity electronic component of a wound therapy ultrasound system intended to convert (transduce) electrical energy into low frequency ultrasound energy for application to a wound site via a fluid mist to promote wound healing. It is a non-contact device which may include a display / controls, intended to connect proximally to the system generator and distally to a disposable applicator. It is used in conjunction with a fluid source such as saline with the ultrasound-conductive mist directed at the wound site for removal of fibrin, yellow slough, tissue exudates, and bacteria.
10816789010201 - UltraMIST Treatment Wand2018-07-06 A hand-held mains electricity electronic component of a wound therapy ultrasound system intended to convert (transduce) electric
00816789010211 - UltraMIST Generator2018-07-06 A portable assembly of mains electricity devices intended to deliver low frequency ultrasound energy via a fluid mist to a wound
20816789010239 - UltraMIST Applicator2018-07-06 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 Applicator2018-07-06 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 Applicator2018-07-06 A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low f
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