AccessGUDID - DEVICE: CELLEX (10705030100009)

GUDID

Device Identifier (DI) Information

Brand Name: CELLEX
Version or Model: CELLEXUSA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CELLEX
Company Name: THERAKOS, INC.

Primary DI Number: 10705030100009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 003083703 *Terms of Use

Device Description: CellEx Instrument

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46912	Photopheresis system	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LNR	SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: RH Non-condensing
Storage Environment Temperature: between 0 and 57 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4a9c8598-ebdf-4f82-9fca-90be2fef6435
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 29, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(855)422-9115
Email: UDI@therakos.com

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