PillCam Genius
GUDID 20884521845845
SB Capsule Endoscopy Kit
Given Imaging, Inc.
Video capsule endoscopy system capsule| Primary Device ID | 20884521845845 |
| NIH Device Record Key | 67eab3de-92df-41e9-adbf-c1160375f42b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PillCam Genius |
| Version Model Number | FGS-0689 |
| Company DUNS | 090073722 |
| Company Name | Given Imaging, Inc. |
| Device Count | 5 |
| 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 | true |
| 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
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521845848 [Primary] |
| GS1 | 20884521845845 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K240276
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-09 |
| Device Publish Date | 2024-11-29 |
On-Brand Devices [PillCam Genius]
| 10884521845831 | PillCam Genius SB Capsule Endoscopy Kit |
| 10884521846975 | PillCam Genius Sync Agent, off-line |
| 20884521845845 | SB Capsule Endoscopy Kit |
Trademark Results [PillCam Genius]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PILLCAM GENIUS 97260892 not registered Live/Pending |
Given Imaging Ltd 2022-02-10 |
 PILLCAM GENIUS 87940313 not registered Live/Pending |
Given Imaging Ltd. 2018-05-29 |
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