AccessGUDID - DEVICE: UltraMIST Single Use Applicator (12 Pack) (00812265010348)

GUDID

Device Identifier (DI) Information

Brand Name: UltraMIST Single Use Applicator (12 Pack)
Version or Model: CP-80040
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sanuwave, Inc.

Primary DI Number: 00812265010348
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832217439 *Terms of Use

Device Description: UltraMIST Single Use Applicator (12 pack Carton) Wound Cleanser

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):	No
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?
62138	Wound therapy ultrasound system	A portable assembly of mains electricity (AC-powered) devices intended to deliver low frequency ultrasound (US) energy, via a fluid mist, to a wound (e.g., skin wound, burn, deep tissue injury, diabetic foot ulcer) to promote healing of the wound without direct wound contact. It consists of a radio-frequency (RF) generator with a fluid pump, handpiece that transduces RF to US, handpiece tip, and appropriate tubing intended to be used with a fluid solution (e.g., saline). The ultrasound-conductive mist is directed at the wound site and intended to remove fibrin, yellow slough, tissue exudates, and bacteria.	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: 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: 33066371-c786-4684-8659-7586ef76b19f
Public Version Date: February 02, 2021
Public Version Number: 1
DI Record Publish Date: January 25, 2021