Primary Device ID | B039SGI00911 |
NIH Device Record Key | 9bbbabd9-ecbb-440f-909e-651b978c03ec |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CryoPRO™-2 |
Version Model Number | SGI-0091 |
Company DUNS | 078487711 |
Company Name | SYNGEN 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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B039SGI00910 [Primary] |
HIBCC | B039SGI00911 [Package] Contains: B039SGI00910 Package: [36 Units] In Commercial Distribution |
HIBCC | B039SGI00919 [Package] Contains: B039SGI00910 Package: [11 Units] In Commercial Distribution |
OAO | Cord Blood Processing System And Storage Container |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-24 |
B039SGI0120010 - SynGenX®-1000 | 2020-02-06 SynGenX®-1000 Docking Station |
B039SGI03050 - SynGenX®-1000 | 2019-09-23 SynGenX®-1000 Disposable Cartridge |
B039SGI0046010 - SynGenX®-1000 | 2018-03-29 SynGenX®-1000 Control Module |
B039SGI00911 - CryoPRO™-2 | 2018-03-29CryoPRO™-2 Cryopreservation/Storage Bag Set |
B039SGI00911 - CryoPRO™-2 | 2018-03-29 CryoPRO™-2 Cryopreservation/Storage Bag Set |
B039SGI04421 - CryoPRO™-5 | 2018-03-29 CryoPRO™-5 Cryopreservation/Storage Bag Set |
B039SGI07770 - SynGen® DataTrak | 2018-03-29 The SynGen™ DataTrak software is the application code that provides the interface between the operator and the SynGenX™-1000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CRYOPRO 90467111 not registered Live/Pending |
Elitelife Int. Ltd 2021-01-14 |
CRYOPRO 86684520 not registered Dead/Abandoned |
THERMOGENESIS CORP. 2015-07-06 |
CRYOPRO 86684503 not registered Dead/Abandoned |
THERMOGENESIS CORP. 2015-07-06 |
CRYOPRO 77328675 3491763 Dead/Cancelled |
Hy-Energy LLC 2007-11-13 |
CRYOPRO 76321589 2707864 Live/Registered |
VWR International, LLC 2001-10-05 |
CRYOPRO 76051431 2467694 Dead/Cancelled |
CRYOPRO, L.L.C. 2000-05-18 |