AccessGUDID - DEVICE: UltraMIST Treatment Wand (00816789010204)

GUDID

Device Identifier (DI) Information

Brand Name: UltraMIST Treatment Wand
Version or Model: CP-80033
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CP-80033
Company Name: ALLIQUA BIOMEDICAL, INC.

Primary DI Number: 00816789010204
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 872967679 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62140	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRB	Wound Cleaner, Ultrasound

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140782	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -25 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7a4eada4-22bd-439f-86af-27a32c118613
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 07, 2016