CELLEX CLXUSA

GUDID 20705030200003

CellEx Procedural Kit

THERAKOS, INC.

Photopheresis system blood set

• Primary Device ID: 20705030200003
• NIH Device Record Key: 13bd9c45-9496-48c5-99c3-6b21dc2ae0f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CELLEX
• Version Model Number: CLXUSA
• Catalog Number: CLXUSA
• Company DUNS: 003083703
• Company Name: THERAKOS, INC.
• Device Count: 4
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705030200006 [Unit of Use]
GS1	20705030200003 [Primary]

FDA Product Code

• LNR: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Sterilization

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

[20705030200003]

Ethylene Oxide

[20705030200003]

Ethylene Oxide

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 [CELLEX]

• 20705030300000: CellEx Light Assembly
• 20705030200003: CellEx Procedural Kit
• 30705030000013: CellEx Instrument
• 30705030000006: CellEx Procedural Kit
• 00705030000050: Cellex Procedural Kit U.S.