UVAR XTS XT125

GUDID 20705030200027

UVAR XTS Procedural Kit (125 ml)

THERAKOS, INC.

Photopheresis system blood set
Primary Device ID20705030200027
NIH Device Record Keybfc7bde0-4222-4fe7-ac66-7b7b762fe7fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameUVAR XTS
Version Model NumberXT125
Catalog NumberXT125
Company DUNS003083703
Company NameTHERAKOS, INC.
Device Count3
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)422-9115
EmailUDI@therakos.com
Phone+1(855)422-9115
EmailUDI@therakos.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110705030200020 [Unit of Use]
GS120705030200027 [Primary]

FDA Product Code

LNRSYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20705030200027]

Ethylene Oxide


[20705030200027]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-08-29

On-Brand Devices [UVAR XTS]

20705030300017UVAR XTS Light Assembly
20705030200027UVAR XTS Procedural Kit (125 ml)
20705030200010UVAR XTS Procedural Kit (225 ml)

Trademark Results [UVAR XTS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UVAR XTS
UVAR XTS
77948145 3949903 Live/Registered
MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
2010-03-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.