EndoFLIP
GUDID 05391530810050
EndoFLIP System
CROSPON LIMITED
Oesophageal motility analysis system Oesophageal motility analysis system Oesophageal motility analysis system Oesophageal motility analysis system Oesophageal motility analysis system Oesophageal motility analysis system Oesophageal motility analysis system Oesophageal motility analysis system Oesophageal motility analysis system Oesophageal motility analysis system Oesophageal motility analysis system Oesophageal motility analysis system Oesophageal motility analysis system Oesophageal motility analysis system Oesophageal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal 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 |
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 |
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 |
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