Primary Device ID | 20705030200010 |
NIH Device Record Key | 5bc122f5-10f0-47f0-96e5-a06aa64fabc5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | UVAR XTS |
Version Model Number | XT001 |
Catalog Number | XT001 |
Company DUNS | 003083703 |
Company Name | THERAKOS, INC. |
Device Count | 3 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(855)422-9115 |
UDI@therakos.com | |
Phone | +1(855)422-9115 |
UDI@therakos.com |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10705030200013 [Unit of Use] |
GS1 | 20705030200010 [Primary] |
LNR | SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL |
Steralize Prior To Use | true |
Device Is Sterile | true |
[20705030200010]
Ethylene Oxide
[20705030200010]
Ethylene Oxide
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2014-08-29 |
20705030300017 | UVAR XTS Light Assembly |
20705030200027 | UVAR XTS Procedural Kit (125 ml) |
20705030200010 | UVAR XTS Procedural Kit (225 ml) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
UVAR XTS 77948145 3949903 Live/Registered |
MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED 2010-03-02 |