Primary Device ID | 30705030000013 |
NIH Device Record Key | 6cc856f8-dbda-45c4-b5a5-38146c1579cc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CELLEX |
Version Model Number | CLXSP-U |
Catalog Number | CLXSP-U |
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 |
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 | |
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 |
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 |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00705030000012 [Primary] |
GS1 | 30705030000013 [Package] Contains: 00705030000012 Package: carton [3 Units] In Commercial Distribution |
LNR | SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-03-08 |
Device Publish Date | 2022-02-28 |
20705030300000 | CellEx Light Assembly |
20705030200003 | CellEx Procedural Kit |
30705030000013 | CellEx Instrument |
30705030000006 | CellEx Procedural Kit |
00705030000050 | Cellex Procedural Kit U.S. |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CELLEX 79211796 5494508 Live/Registered |
Cellex Gesellschaft für Zellgewinnung mbH 2016-08-19 |
CELLEX 78583538 not registered Dead/Abandoned |
JOHNSON & JOHNSON 2005-03-09 |
CELLEX 78471625 3598490 Dead/Cancelled |
Halliburton Energy Services, Inc. 2004-08-23 |
CELLEX 78308710 3610279 Live/Registered |
Cellex Inc 2003-10-02 |
CELLEX 78292504 not registered Dead/Abandoned |
Sealed Air Corporation (US) 2003-08-26 |
CELLEX 77489274 4026448 Live/Registered |
MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED 2008-06-03 |
CELLEX 76537603 2873949 Dead/Cancelled |
Encore Medical Asset Corporation 2003-08-06 |
CELLEX 76136969 not registered Dead/Abandoned |
Cellex Power Products, Inc. 2000-09-26 |
CELLEX 74152930 1691568 Dead/Cancelled |
Boberg, M. Kathleen 1991-04-01 |
CELLEX 74118364 1793428 Dead/Cancelled |
CELLEX MANUFACTURING INC. 1990-11-27 |
CELLEX 73689306 1490725 Dead/Cancelled |
NL INDUSTRIES, INC. 1987-10-13 |
CELLEX 73466726 1345900 Live/Registered |
Actifit, Inc. 1984-02-22 |