EndoFLIP
GUDID 05391530810050
EndoFLIP System
CROSPON LIMITED
Oesophageal motility analysis system| Primary Device ID | 05391530810050 |
| NIH Device Record Key | 03a4359e-e2ca-4c7a-a144-d416ca18774a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EndoFLIP |
| Version Model Number | EF-100 |
| 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 |
Customer Support Contacts
| 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 | |
| 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 | |
| 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 | |
| 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 |
Operating and Storage Conditions
| 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 |
| 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 |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05391530810050 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160725
FDA Product Code
| FFX | System, Gastrointestinal Motility (Electrical) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-08-02 |
On-Brand Devices [EndoFLIP]
| 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 |
Trademark Results [EndoFLIP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOFLIP 77172827 4116590 Live/Registered |
FLIP TECHNOLOGIES LIMITED 2007-05-04 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.