FDA UDI
In Commercial Distribution
🇺🇸 United States
CELLEX
DI: 10705030100009
·
Model: CELLEXUSA
·
THERAKOS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CELLEX
- Primary DI
- 10705030100009
- Version / Model
- CELLEXUSA
- Catalog Number
- CELLEX
- Company Name
- THERAKOS, INC.
- Labeler DUNS
- 003083703
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-08-29
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 4a9c8598-ebdf-4f82-9fca-90be2fef6435
Device Description
CellEx Instrument
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10705030100009 | GS1 |
Customer Contacts
- Phone
- +1(855)422-9115
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- RH Non-condensing
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 57 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity