PillCam FGS-0662
GUDID 07290110360559
PillCam Crohn’s capsule, 1-pack
Covidien LP
Video capsule endoscopy system 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 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 | 07290110360559 |
| NIH Device Record Key | aeae8160-7253-4a84-bb94-e7467400b1ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PillCam |
| Version Model Number | FGS-0662 |
| Catalog Number | FGS-0662 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | |
| 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 | |
| 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 | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290110360559 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170210
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 | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-21 |
On-Brand Devices [PillCam]
| 07290110360825 | PillCamâ„¢ patency capsule, 5-pack |
| 07290110360818 | PillCamâ„¢ patency capsule, 1-pack |
| 07290110360719 | PillCamâ„¢ Recorder DR3 SW upgrade |
| 07290110360566 | PillCam Crohn™ capsule, 10-pack |
| 07290110360559 | PillCam Crohn’s capsule, 1-pack |
| 07290110360542 | PillCam Crohn’s capsule, 5-pack |
| 07290110360221 | PillCamâ„¢ WS v9 Dell T5810, USA |
| 07290110360214 | PillCamâ„¢ Web Software v9, USA |
| 07290110360191 | PillCamâ„¢ Software v9.0 for WS, USA |
| 07290101366904 | recorder DR3 SW upgrade |
| 07290101366768 | PillCam Software Upgrade v9 , USA |
| 07290101366751 | PillCam Software v9.0, USA |
| 07290101366706 | small sensor array |
| 07290101366355 | sensor array |
| 07290101366348 | sensor belt, Small Bowel |
| 07290101366270 | UGI capsule, 10-pack |
| 07290101366263 | UGI capsule, 5-pack |
| 07290101366256 | UGI capsule, 1-pack |
| 07290101366195 | recorder, DR3 cradle kit |
| 07290101366119 | Velcro sleeve, downlink antenna |
| 07290101365891 | sensor array T, DR3 SB3 |
| 07290101365884 | sensor belt 2T, DR3 SB3 |
| 07290101365815 | sensor array, DR3 8-lead sm |
| 07290101365570 | recorder case |
| 07290101364832 | COLON 2 capsule, 10-pack |
| 07290101364825 | COLON 2 capsule, 5-pack |
| 07290101364818 | COLON 2 capsule, 1-pack |
| 07290101364801 | COLON 2 capsule, 10-pack |
| 07290101364795 | COLON 2 capsule, 5-pack |
| 07290101364788 | COLON 2 capsule, 1-pack |
| 07290101364610 | sensor belt 2 disp kit, 5-pk |
| 07290101364603 | sensor belt 2 cover, DR3, SB3 |
| 07290101364474 | recorder cradle, DR3 RFB |
| 07290101364405 | SB 3 capsule, 5-pack |
| 07290101364399 | SB 3 capsule, 1-pack |
| 07290101364382 | SB 3 capsule, 10-pack |
| 07290101364375 | SB 3-EX capsule, 10-pack |
| 07290101364368 | SB 3-EX capsule, 5-pack |
| 07290101364351 | SB 3-EX capsule, 1-pack |
| 07290101364313 | sensor belt cover, DR3, SB3 |
| 07290101364306 | SB 2 capsule, 5-pack |
| 07290101364221 | recorder, DR3 refurbished |
| 07290101364085 | SB 3 capsule, 1-pack |
| 07290101363224 | PillCam recorder pouch, DR2C |
| 07290101363095 | sensor sleeves, 10-pack |
| 07290101363088 | sensor sleeves, 5-pack |
| 07290101363040 | sensor belt, C2 Sleeves |
| 07290101363002 | sensor belt, DR3 C2 |
| 07290101362975 | recorder accessories, DR3 |
| 07290101362968 | recorder cradle, DR3 |
Trademark Results [PillCam]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PILLCAM 98120065 not registered Live/Pending |
Given Imaging Ltd. 2023-08-07 |
 PILLCAM 87130172 5628324 Live/Registered |
Given Imaging Ltd. 2016-08-08 |
 PILLCAM 78450962 3220545 Live/Registered |
GIVEN IMAGING LTD. 2004-07-15 |
 PILLCAM 78083692 not registered Dead/Abandoned |
Given Imagaing Ltd. 2001-09-13 |
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