AccessGUDID - DEVICE: UltraMIST Applicator (00816789010235)

GUDID

Device Identifier (DI) Information

Brand Name: UltraMIST Applicator
Version or Model: CP-80034
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CP-80034
Company Name: ALLIQUA BIOMEDICAL, INC.

Primary DI Number: 00816789010235
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 872967679 *Terms of Use

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.

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:	Yes
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?
62141	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.	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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

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: cd2c453a-87b4-4b62-9034-d54f7ecdebfc
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 07, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
20816789010239	1	10816789010232	In Commercial Distribution	Corrugated carton
10816789010232	6	00816789010235	In Commercial Distribution	Dispenser pack
30816789010236	12	00816789010235	In Commercial Distribution	Dispenser pack
40816789010233	1	30816789010236	In Commercial Distribution	Corrugated Carton