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

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

Sterilization Methods#

Method table
Method

Contacts#

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

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 DIBrandModelCatalogPublished
30705030000013CELLEXCLXSP-UCLXSP-U2022-02-28

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
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