Home GUDID 00812265010348 UltraMIST Single Use Applicator (12 Pack)
Primary DI 00812265010348
Brand UltraMIST Single Use Applicator (12 Pack)
Company SANUWAVE Health, Inc.
Model CP-80040
Device description UltraMIST Single Use Applicator (12 pack Carton) Wound Cleanser
Published 2021-01-25
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name NRB Wound Cleaner, Ultrasound
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NRB Wound Cleaner, Ultrasound General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00812265010348 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00812265010348 00812265010348 812265010348 0812265010348
GMDN Terms# Term, Definition table Term Definition Wound therapy ultrasound system A 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 Type Low High Condition Storage Environment Temperature -25 Degrees Celsius 70 Degrees Celsius
Regulatory Flags# DUNS number 962510686 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00812265010317 UltraMIST Generator SANUWAVE Health, Inc. NRB 2021-01-25 00812265010324 UltraMIST Treatment Wand SANUWAVE Health, Inc. NRB 2021-01-25 00812265010331 UltraMIST Single Use Applicator SANUWAVE Health, Inc. NRB 2021-01-25 00853077002008 Qoustic Wound Therapy System®, Model AR1000 Series AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002015 Qoustic Wound Therapy System® Converter Hand Piece AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002022 Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Support AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002039 Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Base AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002060 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1 AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002077 Qoustic Wound Therapy System®, Model AR1000B Series AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002091 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 4 AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002107 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 6 AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002114 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 7 AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002121 Qoustic Wound Therapy System® Qoustic Key® AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002138 Qoustic Choice® Wound Therapy System, Model AR1000D Series AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002145 Qoustic Choice® Wound Therapy System Converter Hand Piece AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002152 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 11 AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002169 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12 AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002176 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 13 AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002213 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 14 AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002220 Qoustic Wound Therapy System® Ultrasonic Generator AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002237 Qoustic Wound Therapy System® Ultrasonic Generator AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002244 Qoustic Choice® Wound Therapy System Ultrasonic Generator AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002183 Qoustic Choice® Wound Therapy System, Disposable Tubing Set AROBELLA MEDICAL, LLC NRB 2017-01-20 10853077002203 Qoustic Choice® Wound Therapy System, Disposable Tubing Set AROBELLA MEDICAL, LLC NRB 2017-01-20 00816789010204 UltraMIST Treatment Wand ALLIQUA BIOMEDICAL, INC. NRB 2016-09-07 00816789010235 UltraMIST Applicator ALLIQUA BIOMEDICAL, INC. NRB 2016-09-07 00816789010242 MIST 360 Applicator ALLIQUA BIOMEDICAL, INC. NRB 2016-09-07 00816789010259 MIST Therapy Applicator ALLIQUA BIOMEDICAL, INC. NRB 2016-09-07 10816789010201 UltraMIST Treatment Wand ALLIQUA BIOMEDICAL, INC. NRB 2016-09-07 00816789010211 UltraMIST Generator ALLIQUA BIOMEDICAL, INC. NRB 2016-09-07