FDA UDI
In Commercial Distribution
🇺🇸 United States
CELLEX
DI: 00705030000005
·
Model: CLXSP-I
·
Therakos LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CELLEX
- Primary DI
- 00705030000005
- Version / Model
- CLXSP-I
- Catalog Number
- CLXSP-I
- Company Name
- Therakos LLC
- Labeler DUNS
- 003083703
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-28
- Public Version
- 2
- Public Version Date
- 2026-04-24
- Public Version Status
- Update
- Public Device Record Key
- b59c7da1-8e67-4738-b9ff-5a6e6082b018
Device Description
CellEx Procedural Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LNR | SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46913 | Photopheresis system blood set | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30705030000006 | GS1 | Carton | 3 | In Commercial Distribution | |
| Primary | 00705030000005 | GS1 |
Customer Contacts
- Phone
- +1(855)422-9115
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P860003 | 074 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius