CELLEX CLXUSA

GUDID 00705030000050

Cellex Procedural Kit U.S.

THERAKOS, INC.

Photopheresis system blood set

• Primary Device ID: 00705030000050
• NIH Device Record Key: 73fbeb56-d45c-4ec5-96e1-c2ade9ae182c
• 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: 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: 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

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
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• 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	00705030000050 [Primary]

FDA Product Code

• LNR: System, Photopheresis, Extracorporeal

Sterilization

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

[00705030000050]

Ethylene Oxide

[00705030000050]

Ethylene Oxide

[00705030000050]

Ethylene Oxide

[00705030000050]

Ethylene Oxide

[00705030000050]

Ethylene Oxide

[00705030000050]

Ethylene Oxide

[00705030000050]

Ethylene Oxide

[00705030000050]

Ethylene Oxide

[00705030000050]

Ethylene Oxide

[00705030000050]

Ethylene Oxide

[00705030000050]

Ethylene Oxide

[00705030000050]

Ethylene Oxide

[00705030000050]

Ethylene Oxide

[00705030000050]

Ethylene Oxide

[00705030000050]

Ethylene Oxide

[00705030000050]

Ethylene Oxide

[00705030000050]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-15
• Device Publish Date: 2024-11-07

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.