CELLEX

Basic Information

• Brand Name: CELLEX
• Primary DI: 00705030000012
• Version / Model: CLXSP-U
• Catalog Number: CLXSP-U
• Company Name: THERAKOS, INC.
• Labeler DUNS: 003083703
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-28
• Public Version: 1
• Public Version Date: 2022-03-08
• Public Version Status: New
• Public Device Record Key: 6cc856f8-dbda-45c4-b5a5-38146c1579cc

Device Description

CellEx Instrument

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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
46912	Photopheresis system	An assembly of devices used for extracorporeal photoimmunetherapy to treat immune disorders, especially cutaneous T-cell lymphoma (CTCL). A photoactivatable drug (psoralen) is ingested by the patient, after which peripheral blood is drawn into a disposable set that is installed in the system's main unit (or the drug is later injected into a subsequent leukocyte-enriched fraction). The white cells or buffy coat and a small amount of plasma are isolated, via the system's centrifuge, and together with the drug are irradiated with ultraviolet A (UVA) from a lamp assembly. The treated leukocyte-enriched component and untreated blood components are returned to the patient for treatment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30705030000013	GS1	carton	3	In Commercial Distribution
Primary	00705030000012	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P860003	074

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: RH Non-condensing
• Type: Storage Environment Temperature
• Temperature Range: 0 – 57 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity