CELLEX CLXSP-U

GUDID 30705030000013

CellEx Instrument

THERAKOS, INC.

Photopheresis system

• Primary Device ID: 30705030000013
• NIH Device Record Key: 6cc856f8-dbda-45c4-b5a5-38146c1579cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CELLEX
• Version Model Number: CLXSP-U
• Catalog Number: CLXSP-U
• Company DUNS: 003083703
• Company Name: THERAKOS, INC.
• Device Count: 1
• DM Exempt: false
• 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
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com
• Phone: +1(855)422-9115
• Email: UDI@therakos.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *RH Non-condensing
• Storage Environment Temperature: Between 0 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00705030000012 [Primary]
GS1	30705030000013 [Package]; Contains: 00705030000012; Package: carton [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P860003

FDA Product Code

• LNR: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-08
• Device Publish Date: 2022-02-28

On-Brand Devices [CELLEX]

• 20705030300000: CellEx Light Assembly
• 20705030200003: CellEx Procedural Kit
• 30705030000013: CellEx Instrument
• 30705030000006: CellEx Procedural Kit