Valleylab

Basic Information

• Brand Name: Valleylab
• Primary DI: 10884521740860
• Version / Model: SEL7010
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-03
• Public Version: 3
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: 71df30df-227d-403d-92fc-8ef24defedc9

Device Description

Laparoscopic Smoke Evacuation System Active and Passive

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: Yes
• 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
NKC	Tubing/tubing with filter, insufflation, laparoscopic	Obstetrics/Gynecology	884.1730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60836	Laparoscopic plume filter	A sterile device intended to be used during minimally-invasive surgery, in particular laparoscopic surgery, to filter surgical smoke (plume created by, e.g., electrosurgical diathermy, a laser or sonic scalpel) of potentially harmful agents (e.g., noxious chemicals, particulates, viruses, bacteria) without loss of pneumoperitoneum. It is typically a multi-layered filter pouch intended to be connected to a trocar stopcock; it is intended to help protect surgical staff from ambient exposure to potentially harmful agents. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521740867	GS1	CASE	10	In Commercial Distribution
Primary	10884521740860	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry.
• Type: Handling Environment Temperature
• Temperature Range: -20 – 140 Degrees Fahrenheit