UltraMIST Generator

Basic Information

• Brand Name: UltraMIST Generator
• Primary DI: 00812265010317
• Version / Model: CP-80031
• Company Name: Sanuwave, Inc.
• Labeler DUNS: 832217439
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-25
• Public Version: 1
• Public Version Date: 2021-02-02
• Public Version Status: New
• Public Device Record Key: c4954e14-35bf-482a-bac9-789cae03c679

Device Description

The UltraMIST Generator

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRB	Wound Cleaner, Ultrasound	General, Plastic Surgery	878.4410	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812265010317	GS1
Previous	00816789010211	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140782	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius