CELLEX

Primary DI
00705030000005
Brand
CELLEX
Company
Therakos LLC
Model
CLXSP-I
Catalog number
CLXSP-I
Device description
CellEx Procedural Kit
Published
2022-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNRSYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P860003074

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P860003074UVAR PHOTOPHERESIS SYSTEMTherakos Development Limited1987-04-08LNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705030000006PackageGS13In Commercial Distribution
00705030000005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3070503000000630705030000006
00705030000005007050300000057050300000050705030000005

GMDN Terms#

Term, Definition table
TermDefinition
Photopheresis system blood setA 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
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
003083703
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705030100009CELLEXCELLEXUSACELLEX2014-08-29
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
00705030000012CELLEXTherakos LLCLNR2022-02-28
30705030000006CELLEXTHERAKOS, INC.LNR2022-02-28
30705030000013CELLEXTHERAKOS, INC.LNR2022-02-28
10705030100009CELLEXTherakos LLCLNR2014-08-29
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