MIST Therapy Applicator CP-80011

GUDID 20816789010253

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. This is a single-use device.

ALLIQUA BIOMEDICAL, INC.

Wound therapy ultrasound system handpiece tip
Primary Device ID20816789010253
NIH Device Record Keydc457ca1-9f2f-42e4-82e2-e97939077774
Commercial Distribution StatusIn Commercial Distribution
Brand NameMIST Therapy Applicator
Version Model NumberCP-80011
Catalog NumberCP-80011
Company DUNS872967679
Company NameALLIQUA BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-963-2273
EmailMIST.CS@alliqua.com
Phone844-963-2273
EmailMIST.CS@alliqua.com
Phone844-963-2273
EmailMIST.CS@alliqua.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816789010259 [Primary]
GS110816789010256 [Package]
Contains: 00816789010259
Package: Kit tray [1 Units]
In Commercial Distribution
GS120816789010253 [Package]
Contains: 10816789010256
Package: Corrugated carton [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRBWound Cleaner, Ultrasound

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20816789010253]

Radiation Sterilization


[20816789010253]

Radiation Sterilization


[20816789010253]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-07

Devices Manufactured by ALLIQUA BIOMEDICAL, INC.

10816789010201 - UltraMIST Treatment Wand2018-07-06 A hand-held mains electricity electronic component of a wound therapy ultrasound system intended to convert (transduce) electric
00816789010211 - UltraMIST Generator2018-07-06 A portable assembly of mains electricity devices intended to deliver low frequency ultrasound energy via a fluid mist to a wound
20816789010239 - UltraMIST Applicator2018-07-06 A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low f
20816789010246 - MIST 360 Applicator2018-07-06 A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low f
20816789010253 - MIST Therapy Applicator2018-07-06A 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. This is a single-use device.
20816789010253 - MIST Therapy Applicator2018-07-06 A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low f

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