Home GUDID 10816789010201 UltraMIST Treatment Wand
Primary DI 10816789010201
Brand UltraMIST Treatment Wand
Company ALLIQUA BIOMEDICAL, INC.
Model CP-80033
Catalog number CP-80033
Device description 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.
Published 2016-09-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 10816789010201 Package GS1 1 In Commercial Distribution 00816789010204 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 10816789010201 10816789010201 00816789010204 00816789010204 816789010204 0816789010204
GMDN Terms# Term, Definition table Term Definition Wound therapy ultrasound system handpiece A hand-held mains electricity (DC-powered) electronic component of a wound therapy ultrasound (US) system intended to convert (transduce) electrical energy into low frequency US energy for application to a wound site, via a fluid mist, to promote wound healing. It is a non-patient-contact device, which may include a display/controls, intended to connect proximally to the system generator and distally to a handpiece tip. It is used in conjunction with a fluid source (e.g., saline), whereby an ultrasound-conductive mist is directed at the wound site for removal of fibrin, yellow slough, tissue exudates, and bacteria. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -25 Degrees Celsius 70 Degrees Celsius
Regulatory Flags# DUNS number 872967679 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 00812265010348 UltraMIST Single Use Applicator (12 Pack) 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 00816789010211 UltraMIST Generator ALLIQUA BIOMEDICAL, INC. NRB 2016-09-07
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