Valleylab

Basic Information

• Brand Name: Valleylab
• Primary DI: 10884521767911
• Version / Model: E3530-6
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-07
• Public Version: 4
• Public Version Date: 2023-10-10
• Public Version Status: Update
• Public Device Record Key: b92edfe3-8f11-449a-80a5-8d5843ab64b0

Device Description

Flexible Argon Electrode Coagulation Only

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
61878	Inert gas-enhanced endoscopic electrosurgical electrode, single-use	An invasive, distal component of an inert gas-enhanced electrosurgical system intended to deliver electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] directly to tissues for cutting/coagulation/ablation during an endoscopic (including laparoscopic, arthroscopic) surgical procedure. It is a long thin device with no controls, typically designed as a coaxial arrangement of a monopolar electrode within a gas delivery tube/sleeve, which requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., rigid laparoscopic electrode, flexible endoscopic probe). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521767918	GS1	PACK_OR_INNER_PACK	10	In Commercial Distribution
Primary	10884521767911	GS1
Package	30884521767915	GS1	CASE	15	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	6	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -22 – 140 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry