CELLEX

Basic Information

• Brand Name: CELLEX
• Primary DI: 00705030000029
• Version / Model: CLXCC-I
• Catalog Number: CLXCC-I
• Company Name: THERAKOS, INC.
• Labeler DUNS: 003083703
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-01
• Public Version: 1
• Public Version Date: 2022-11-09
• Public Version Status: New
• Public Device Record Key: f8ed020e-517c-4556-91f6-fe211a02c420

Device Description

CellEX Procedural Kit RoHS 3 Correct Connect (OUS)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
46913	Photopheresis system blood set	A collection of devices used as part of a photopheresis system for extracorporeal photoimmunetherapy to treat immune disorders, especially cutaneous T-cell lymphoma (CTCL). It typically consists of tubing (patient and fluid lines), fluid/blood component bags, a dedicated centrifuge bowl, a photoactivation chamber, connectors, and clamps. It conducts blood from the patient to the system's main unit, aids in blood processing, and returns leukocyte-enriched and untreated components of the blood after irradiation. This is a sterile, single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00705030000029	GS1
Package	30705030000020	GS1	Carton	3	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P860003	074

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius