DYONICS POWER

Basic Information

• Brand Name: DYONICS POWER
• Primary DI: 03596010420121
• Version / Model: 7205888
• Catalog Number: 7205888
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-23
• Public Version: 4
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 9a2bb5f9-0ac8-4cea-8fd7-0ac9e49e80dc

Device Description

DYONICS POWER INTL KIT 230-240V

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
HRX	ARTHROSCOPE	Orthopedic	888.1100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48169	Insufflation gas conditioning system control unit	A mains electricity (AC-powered) device designed to be used together with a laparoscopic gas distention system or other gas source to condition the insufflation gas stream [typically carbon dioxide (CO2)] by automatically heating and humidifying the gas before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It is electronically controlled and has controls and displays for the user to operate and monitor the gas conditioning process which happens within an interchangeable humidification chamber that is fitted to this device. The gas is delivered to the operative site via a dedicated heated tubing set.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03596010420121	GS1

Customer Contacts

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