Home GUDID 30705030000006 CELLEX
Primary DI 30705030000006
Brand CELLEX
Company THERAKOS, INC.
Model CLXSP-I
Catalog number CLXSP-I
Device description CellEx Procedural Kit
Published 2022-02-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name LNR SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LNR System, Photopheresis, Extracorporeal Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30705030000006 Package GS1 3 In Commercial Distribution 00705030000005 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 30705030000006 30705030000006 00705030000005 00705030000005 705030000005 0705030000005
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -20 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 003083703 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex true No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 30705030000013 CELLEX CLXSP-U CLXSP-U 2022-02-28
Other Devices Sharing Product Codes# 
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