Home GUDID 00816789010235 UltraMIST Applicator
Primary DI 00816789010235
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
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 Lot or batch true Expiration date on label true 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 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
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