FDA.reportPublic FDA data

UltraMIST Generator

Primary DI
00816789010211
Brand
UltraMIST Generator
Company
ALLIQUA BIOMEDICAL, INC.
Model
CP-80031
Catalog number
CP-80031
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.
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRBWound Cleaner, Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRBWound Cleaner, UltrasoundGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140782000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140782000ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATORCelleration, Inc.2014-08-13NRB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816789010218PackageGS11In Commercial Distribution
00816789010211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081678901021810816789010218
00816789010211008167890102118167890102110816789010211

GMDN Terms#

Term, Definition table
TermDefinition
Wound therapy ultrasound system generatorA 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-963-2273MIST.CS@Alliqua.com

Regulatory Flags#

DUNS number
872967679
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816789010204UltraMIST Treatment WandCP-80033CP-800332016-09-07
00816789010235UltraMIST ApplicatorCP-80034CP-800342016-09-07
00816789010242MIST 360 ApplicatorCP-80024CP-800242016-09-07
00816789010259MIST Therapy ApplicatorCP-80011CP-800112016-09-07
10816789010201UltraMIST Treatment WandCP-80033CP-800332016-09-07
20816789010239UltraMIST ApplicatorCP-80034CP-800342016-09-07
20816789010246MIST 360 ApplicatorCP-80024CP-800242016-09-07
20816789010253MIST Therapy ApplicatorCP-80011CP-800112016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812265010317UltraMIST GeneratorSANUWAVE Health, Inc.NRB2021-01-25
00812265010324UltraMIST Treatment WandSANUWAVE Health, Inc.NRB2021-01-25
00812265010331UltraMIST Single Use ApplicatorSANUWAVE Health, Inc.NRB2021-01-25
00812265010348UltraMIST Single Use Applicator (12 Pack)SANUWAVE Health, Inc.NRB2021-01-25
00853077002008Qoustic Wound Therapy System®, Model AR1000 SeriesAROBELLA MEDICAL, LLCNRB2017-03-01
00853077002015Qoustic Wound Therapy System® Converter Hand PieceAROBELLA MEDICAL, LLCNRB2017-03-01
00853077002022Qoustic Wound Therapy System®, Cart, AR Series, Type 1, SupportAROBELLA MEDICAL, LLCNRB2017-03-01
00853077002039Qoustic Wound Therapy System®, Cart, AR Series, Type 1, BaseAROBELLA MEDICAL, LLCNRB2017-03-01
00853077002060Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1AROBELLA MEDICAL, LLCNRB2017-03-01
00853077002077Qoustic Wound Therapy System®, Model AR1000B SeriesAROBELLA MEDICAL, LLCNRB2017-03-01
00853077002091Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 4AROBELLA MEDICAL, LLCNRB2017-03-01
00853077002107Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 6AROBELLA MEDICAL, LLCNRB2017-03-01
00853077002114Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 7AROBELLA MEDICAL, LLCNRB2017-03-01
00853077002121Qoustic Wound Therapy System® Qoustic Key®AROBELLA MEDICAL, LLCNRB2017-03-01
00853077002138Qoustic Choice® Wound Therapy System, Model AR1000D SeriesAROBELLA MEDICAL, LLCNRB2017-03-01
00853077002145Qoustic Choice® Wound Therapy System Converter Hand PieceAROBELLA MEDICAL, LLCNRB2017-03-01
00853077002152Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 11AROBELLA MEDICAL, LLCNRB2017-03-01
00853077002169Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12AROBELLA MEDICAL, LLCNRB2017-03-01
00853077002176Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 13AROBELLA MEDICAL, LLCNRB2017-03-01
00853077002213Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 14AROBELLA MEDICAL, LLCNRB2017-03-01
00853077002220Qoustic Wound Therapy System® Ultrasonic GeneratorAROBELLA MEDICAL, LLCNRB2017-03-01
00853077002237Qoustic Wound Therapy System® Ultrasonic GeneratorAROBELLA MEDICAL, LLCNRB2017-03-01
00853077002244Qoustic Choice® Wound Therapy System Ultrasonic GeneratorAROBELLA MEDICAL, LLCNRB2017-03-01
00853077002183Qoustic Choice® Wound Therapy System, Disposable Tubing SetAROBELLA MEDICAL, LLCNRB2017-01-20
10853077002203Qoustic Choice® Wound Therapy System, Disposable Tubing SetAROBELLA MEDICAL, LLCNRB2017-01-20
00816789010204UltraMIST Treatment WandALLIQUA BIOMEDICAL, INC.NRB2016-09-07
00816789010235UltraMIST ApplicatorALLIQUA BIOMEDICAL, INC.NRB2016-09-07
00816789010242MIST 360 ApplicatorALLIQUA BIOMEDICAL, INC.NRB2016-09-07
00816789010259MIST Therapy ApplicatorALLIQUA BIOMEDICAL, INC.NRB2016-09-07
10816789010201UltraMIST Treatment WandALLIQUA BIOMEDICAL, INC.NRB2016-09-07