Valleylab SM

Basic Information

• Brand Name: Valleylab SM
• Primary DI: 10884521855373
• Version / Model: VSMPA22
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2025-07-10
• Public Version: 1
• Public Version Date: 2025-07-18
• Public Version Status: New
• Public Device Record Key: d3350c0f-2bd7-4b06-a9b3-cd3dab307411

Device Description

Smoke Management Pencil Adapter

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: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QGI	Air-Handling Apparatus Accessory	General, Plastic Surgery	878.5080	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46483	Surgical plume evacuation system tube	A long, hollow cylinder which, as part of a surgical plume evacuation system, is intended to be used to capture, conduct, and exhaust the plume of smoke generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521855370	GS1	CASE	8	In Commercial Distribution
Primary	10884521855373	GS1
Unit of Use	30884521855377	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -30 – 60 Degrees Celsius