CapsoView 2759
GUDID 00867770000216
Software
CAPSOVISION, INC.
Video capsule endoscopy system application software| Primary Device ID | 00867770000216 |
| NIH Device Record Key | 58fb39ca-28c0-4179-bd16-9ba7842408cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CapsoView |
| Version Model Number | 3 |
| Catalog Number | 2759 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00867770000216 [Primary] |
| GS1 | 08677700002027 [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 | 4 |
| Public Version Date | 2020-02-24 |
| 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 | 2020-02-25 Capsule Data Access System |
| 00867770000216 - CapsoView | 2020-02-24Software |
| 00867770000216 - CapsoView | 2020-02-24 Software |
| 00867770000247 - CapsoRetrieve | 2020-02-24 Capsule Retrieval Kit |
Trademark Results [CapsoView]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPSOVIEW 86655509 4967667 Live/Registered |
CapsoVision, Inc. 2015-06-08 |
 CAPSOVIEW 86068763 4664585 Live/Registered |
CapsoVision, Inc. 2013-09-18 |
 CAPSOVIEW 77736220 3998670 Live/Registered |
Capso Vision, Inc. 2009-05-13 |
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