CapsoAccess 5373
GUDID 00867770000230
Capsule Data Access System
CAPSOVISION, INC.
Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule| Primary Device ID | 00867770000230 |
| NIH Device Record Key | 41395993-fdb6-43d4-9185-27e34b346d2e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CapsoAccess |
| Version Model Number | 3 |
| Catalog Number | 5373 |
| Company DUNS | 789635740 |
| Company Name | CAPSOVISION, 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 | true |
| Serial Number | false |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00867770000230 [Primary] |
| GS1 | 08677700002034 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161773
FDA Product Code
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-02-25 |
| Device Publish Date | 2018-07-17 |
Devices Manufactured by CAPSOVISION, INC.
| 00867770000261 - CapsoCam Plus | 2020-12-21 Convenience Kit: Small Bowel Capsule Endoscope and Capsule Retrieval Kit |
| 00867770000254 - CapsoRetrieve | 2020-10-06 Capsule Retrieval Kit Pan |
| 00867770000223 - CapsoCloud | 2020-03-10 Web-based software for managing the CapsoCam Plus procedures used by health care providers, readers, download centers, and uploa |
| 00867770000209 - CapsoCam Plus | 2020-02-25 Small Bowel Capsule Endoscope |
| 00867770000230 - CapsoAccess | 2020-02-25Capsule Data Access System |
| 00867770000230 - CapsoAccess | 2020-02-25 Capsule Data Access System |
| 00867770000216 - CapsoView | 2020-02-24 Software |
| 00867770000247 - CapsoRetrieve | 2020-02-24 Capsule Retrieval Kit |
Trademark Results [CapsoAccess]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPSOACCESS 86655577 4976535 Live/Registered |
CapsoVision, Inc. 2015-06-09 |
 CAPSOACCESS 86068757 4633850 Live/Registered |
CapsoVision, Inc. 2013-09-18 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.