CELLEX

Primary DI
30705030000013
Brand
CELLEX
Company
THERAKOS, INC.
Model
CLXSP-U
Catalog number
CLXSP-U
Device description
CellEx Instrument
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
false

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
30705030000013PackageGS13In Commercial Distribution
00705030000012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3070503000001330705030000013
00705030000012007050300000127050300000120705030000012

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

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
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30705030000006CELLEXCLXSP-ICLXSP-I2022-02-28

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
30705030000006CELLEXTHERAKOS, 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