PillCam FGS-0154

GUDID 07290101363194

sensor array, DR2 8-lead

Given Imaging, Inc.

Video capsule endoscopy system Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna Video capsule endoscopy system antenna

• Primary Device ID: 07290101363194
• NIH Device Record Key: 7b28a83b-0f62-4473-b296-130fcc08bfa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PillCam
• Version Model Number: FGS-0154
• Catalog Number: FGS-0154
• Company DUNS: 090073722
• Company Name: Given Imaging, 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290101363194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101250

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [PillCam]

• 07290101365686: sensor array, DR2 8-lead
• 07290101364146: sensor belt, DR3 SB3
• 07290101363231: recorder accessories DR2 sm
• 07290101363200: sensor array, DR2 3-lead
• 07290101363194: sensor array, DR2 8-lead
• 07290101362845: sensor belt, DR2, SB