Primary Device ID | 05391530810142 |
NIH Device Record Key | 2a7ff776-d269-4a9f-8cd8-85d2b053029c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EndoFLIP |
Version Model Number | DD-961 |
Company DUNS | 989779517 |
Company Name | CROSPON LIMITED |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
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 | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com | |
Phone | 8582767766 |
info@crospon.com |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 160 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05391530810142 [Primary] |
FFX | System, Gastrointestinal Motility (Electrical) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-11-08 |
Device Publish Date | 2017-06-24 |
05391530810142 | FLIP Topography Module |
05391530810050 | EndoFLIP System |
05391530810029 | EndoFLIP Measurement Catheter for use with EndoFLIP System |
05391530810012 | EndoFLIP Measurement Catheter for use with EndoFLIP System |
05391530810005 | EndoFLIP Measurement Catheter for use with EndoFLIP System |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ENDOFLIP 77172827 4116590 Live/Registered |
FLIP TECHNOLOGIES LIMITED 2007-05-04 |