Renuvion®/J-Plasma®

Basic Information

• Brand Name: Renuvion®/J-Plasma®
• Primary DI: 00607151050122
• Version / Model: APYX-HGS
• Catalog Number: APYX-HGS
• Company Name: APYX MEDICAL CORPORATION
• Labeler DUNS: 101223287
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-23
• Public Version: 3
• Public Version Date: 2022-10-31
• Public Version Status: Update
• Public Device Record Key: 6cd2ef95-fa6e-4f9f-b597-1c8206c001d1

Device Description

Renuvion®/J-Plasma® Helium Gas Regulator

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: 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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60328	Calibration gas cylinder regulator	A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of an calibration gas cylinder to lower high, variable gas pressure to a lower, constant working pressure, and may provide a pre-set flow rate of calibration gas for calibration of e.g., an anaesthesia monitor. It can be a single or a dual stage regulator, usually of a piston or diaphragm design. It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may have associated devices, usually a manometer or manometers, to display the available gas reserve of a gas cylinder and the working pressure.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00607151050122	GS1

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius