ONETRAC LXS

Basic Information

• Brand Name: ONETRAC LXS
• Primary DI: 00850040140453
• Version / Model: Frazier - 8 Fr
• Catalog Number: C110310
• Company Name: OBP Surgical Corporation
• Labeler DUNS: 118262590
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-21
• Public Version: 1
• Public Version Date: 2023-07-31
• Public Version Status: New
• Public Device Record Key: 39207eb8-f41e-4ce5-91f7-46584c04b995

Device Description

ONETRAC LXS single-use suction device with integrated cordless radial LED light source, Frazier, 8 Fr

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: Yes
• 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
JOL	Catheter And Tip, Suction	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38518	Surgical/emergency suction cannula, illuminating, single-use	An atraumatic, invasive, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or clear an airway obstruction, whilst providing illumination of the site. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic, nor an intravascular device; it is not designed for surgical irrigation. It has a built-in light or fibreoptic bundle used to illuminate the operative site. Often referred to a as suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850040140453	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 45 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius