FDA.reportPublic FDA data

UltraMIST Generator

Primary DI
00812265010317
Brand
UltraMIST Generator
Company
SANUWAVE Health, Inc.
Model
CP-80031
Device description
The UltraMIST Generator
Published
2021-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00816789010211PreviousGS10
00812265010317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816789010211008167890102118167890102110816789010211
00812265010317008122650103178122650103170812265010317

GMDN Terms#

Term, Definition table
TermDefinition
Wound therapy ultrasound systemA portable assembly of mains electricity (AC-powered) devices intended to deliver low frequency ultrasound (US) energy, via a fluid mist, to a wound (e.g., skin wound, burn, deep tissue injury, diabetic foot ulcer) to promote healing of the wound without direct wound contact. It consists of a radio-frequency (RF) generator with a fluid pump, handpiece that transduces RF to US, handpiece tip, and appropriate tubing intended to be used with a fluid solution (e.g., saline). The ultrasound-conductive mist is directed at the wound site and intended to remove fibrin, yellow slough, tissue exudates, and bacteria.

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
678-578-0108order@sanuwave.com

Regulatory Flags#

DUNS number
962510686
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812265010201dermaPACE ApplicatorDAP03322021-01-25
00812265010218dermaPACE ConsoleDEP03302021-01-25
00812265010225dermaPACE System (Console with applicator)DEP0330/DAP03322021-01-25
00812265010287Profile ConsolePRF1002021-01-25
00812265010294Profile Applicator FLE01032021-01-25
00812265010300Profile Applicator FLE01042021-01-25
00812265010324UltraMIST Treatment WandCP-800332021-01-25
00812265010331UltraMIST Single Use ApplicatorAS-550572021-01-25
00812265010348UltraMIST Single Use Applicator (12 Pack)CP-800402021-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00816789010211UltraMIST GeneratorALLIQUA BIOMEDICAL, INC.NRB2016-09-07