UVAR XTS UVAR XTS
GUDID 10705030100016
UVAR XTS Instrument
THERAKOS, INC.
Photopheresis system| Primary Device ID | 10705030100016 |
| NIH Device Record Key | 7c0a527d-a930-4aa6-9c76-370958aa284c |
| Commercial Distribution Discontinuation | 2025-05-07 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | UVAR XTS |
| Version Model Number | UVAR XTS |
| Catalog Number | UVAR XTS |
| Company DUNS | 003083703 |
| Company Name | THERAKOS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(855)422-9115 |
| UDI@therakos.com | |
| Phone | +1(855)422-9115 |
| UDI@therakos.com | |
| Phone | +1(855)422-9115 |
| UDI@therakos.com | |
| Phone | +1(855)422-9115 |
| UDI@therakos.com | |
| Phone | +1(855)422-9115 |
| UDI@therakos.com | |
| Phone | +1(855)422-9115 |
| UDI@therakos.com | |
| Phone | +1(855)422-9115 |
| UDI@therakos.com | |
| Phone | +1(855)422-9115 |
| UDI@therakos.com | |
| Phone | +1(855)422-9115 |
| UDI@therakos.com | |
| Phone | +1(855)422-9115 |
| UDI@therakos.com | |
| Phone | +1(855)422-9115 |
| UDI@therakos.com | |
| Phone | +1(855)422-9115 |
| UDI@therakos.com | |
| Phone | +1(855)422-9115 |
| UDI@therakos.com | |
| Phone | +1(855)422-9115 |
| UDI@therakos.com | |
| Phone | +1(855)422-9115 |
| UDI@therakos.com | |
| Phone | +1(855)422-9115 |
| UDI@therakos.com | |
| Phone | +1(855)422-9115 |
| UDI@therakos.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
| Storage Environment Temperature | Between 0 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *RH Non-condensing |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705030100016 [Primary] |
FDA Product Code
| LNR | SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2025-05-09 |
| Device Publish Date | 2014-08-29 |
On-Brand Devices [UVAR XTS]
| 20705030300017 | UVAR XTS Light Assembly |
| 20705030200027 | UVAR XTS Procedural Kit (125 ml) |
| 20705030200010 | UVAR XTS Procedural Kit (225 ml) |
| 10705030100016 | UVAR XTS Instrument |
Trademark Results [UVAR XTS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UVAR XTS 77948145 3949903 Live/Registered |
MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED 2010-03-02 |
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