UVAR XTS XT20

GUDID 20705030300017

UVAR XTS Light Assembly

THERAKOS, INC.

Photopheresis system lamp assembly

• Primary Device ID: 20705030300017
• NIH Device Record Key: 7d293a8b-f7d7-4fea-a91b-8ac06aa45ef0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UVAR XTS
• Version Model Number: XT20
• Catalog Number: XT20
• Company DUNS: 003083703
• Company Name: THERAKOS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705030300017 [Primary]

FDA Product Code

• LNR: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-08-29

On-Brand Devices [UVAR XTS]

• 20705030300017: UVAR XTS Light Assembly
• 20705030200027: UVAR XTS Procedural Kit (125 ml)
• 20705030200010: UVAR XTS Procedural Kit (225 ml)