CELLEX

Primary DI
10705030100009
Brand
CELLEX
Company
Therakos LLC
Model
CELLEXUSA
Catalog number
CELLEX
Device description
CellEx Instrument
Published
2014-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNRSYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNRSystem, Photopheresis, ExtracorporealUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705030100009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503010000910705030100009

GMDN Terms#

Term, Definition table
TermDefinition
Photopheresis systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00RH Non-condensing
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius57 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(855)422-9115UDI@therakos.com

Regulatory Flags#

DUNS number
003083703
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00705030000005CELLEXCLXSP-ICLXSP-I2022-02-28
00705030000012CELLEXCLXSP-UCLXSP-U2022-02-28
00705030000029CELLEXCLXCC-ICLXCC-I2022-11-01
00705030000036CELLEXCLXCC-UCLXCC-U2022-11-01
10705030100016UVAR XTSUVAR XTSUVAR XTS2014-08-29
00705030000050CELLEXCLXUSACLXUSA2024-11-07
20705030200003CELLEXCLXUSACLXUSA2014-08-29
20705030200010UVAR XTSXT001XT0012014-08-29
20705030200027UVAR XTSXT125XT1252014-08-29
20705030300000CELLEXCLXLGTCLXLGT2014-08-29
20705030300017UVAR XTSXT20XT202014-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00705030000050CELLEXTherakos LLCLNR2024-11-07
00705030000029CELLEXTherakos LLCLNR2022-11-01
00705030000036CELLEXTherakos LLCLNR2022-11-01
00705030000005CELLEXTherakos LLCLNR2022-02-28
00705030000012CELLEXTherakos LLCLNR2022-02-28
30705030000006CELLEXTHERAKOS, INC.LNR2022-02-28
30705030000013CELLEXTHERAKOS, INC.LNR2022-02-28
10705030100016UVAR XTSTherakos LLCLNR2014-08-29
20705030200003CELLEXTherakos LLCLNR2014-08-29
20705030200010UVAR XTSTherakos LLCLNR2014-08-29
20705030200027UVAR XTSTherakos LLCLNR2014-08-29
20705030300000CELLEXTherakos LLCLNR2014-08-29
20705030300017UVAR XTSTherakos LLCLNR2014-08-29