Home GUDID 20816789010239 UltraMIST Applicator
Primary DI 20816789010239
Brand UltraMIST Applicator
Company ALLIQUA BIOMEDICAL, INC.
Model CP-80034
Catalog number CP-80034
Device description A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low frequency ultrasound energy from the treatment wand with a fluid solution (e.g., saline) for the production of an ultrasound-conductive mist used to promote wound healing. It typically includes fluid delivery tubing and is intended to fit on the distal end of the treatment wand. This is a single-use device.
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 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 10816789010232 Package GS1 6 In Commercial Distribution 20816789010239 Package GS1 1 In Commercial Distribution 30816789010236 Package GS1 12 In Commercial Distribution 40816789010233 Package GS1 1 In Commercial Distribution 00816789010235 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 10816789010232 10816789010232 20816789010239 20816789010239 30816789010236 30816789010236 40816789010233 40816789010233 00816789010235 00816789010235 816789010235 0816789010235
GMDN Terms# Term, Definition table Term Definition Wound therapy ultrasound system handpiece tip A sterile component of a wound therapy ultrasound (US) system intended to be attached to the system handpiece to interface low frequency US energy from the handpiece with a fluid solution (e.g., saline) for the production of an ultrasound-conductive mist used to promote wound healing. It typically includes fluid delivery tubing and is intended to fit on the distal end of the handpiece. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -25 Degrees Celsius 70 Degrees Celsius
Sterilization Methods# Method table Method Radiation Sterilization
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 true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use 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 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 10816789010201 UltraMIST Treatment Wand ALLIQUA BIOMEDICAL, INC. NRB 2016-09-07
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