UVAR XTS

Basic Information

• Brand Name: UVAR XTS
• Primary DI: 20705030300017
• Version / Model: XT20
• Catalog Number: XT20
• Company Name: THERAKOS, INC.
• Labeler DUNS: 003083703
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-08-29
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 7d293a8b-f7d7-4fea-a91b-8ac06aa45ef0

Device Description

UVAR XTS Light Assembly

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: Yes
• 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
LNR	SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
46914	Photopheresis system lamp assembly	An assembly of ultraviolet A (UVA)-emitting tubular strip lights that is an exchangeable component of a photopheresis system, and used to irradiate blood components during extracorporeal photoimmunetherapy to treat immune disorders, especially cutaneous T-cell lymphoma (CTCL). It typically consists of a replaceable assembly having a bank of several lamps that are electronically monitored and tracked by the main unit, so that notification of pending replacement after the recommended usage time (e.g., 150 hours) is provided to the operator of the system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20705030300017	GS1

Customer Contacts

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