Valleylab

Basic Information

• Brand Name: Valleylab
• Primary DI: 10884524002569
• Version / Model: Force Argon II-8
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: 2604e14a-4f38-4721-a9a4-5b187168af46

Device Description

Argon Gas Delivery Unit II,240 V

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
36155	Inert gas-enhanced electrosurgical system generator	An electrically-powered component of an inert gas-enhanced electrosurgical system that serves as the source of inert gas [e.g., argon (Ar), helium (He)] and generates a high frequency electrical current in selected radio-frequency (RF) bands between two electrodes to produce heat in tissues for cutting and coagulating during surgery. The gas is delivered via this device and through a connected handpiece unit that ensures that the gas is channelled around the cutting electrode; a process which lessens the charring of tissue and provides rapid, uniform coagulation over large bleeding surfaces.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884524002569	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K964636	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -40 – 158 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity