PillCam

GUDID 10884521845923

PillCam (TM) Desktop Software v9.7 Upgrade

Given Imaging, Inc.

Video capsule endoscopy system application software

• Primary Device ID: 10884521845923
• NIH Device Record Key: 077e6d3e-91af-41e3-b2d9-d549afb30757
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PillCam
• Version Model Number: FGS-0803
• Company DUNS: 090073722
• Company Name: Given Imaging, Inc.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521845923 [Primary]

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: 2024-11-22
• Device Publish Date: 2024-11-14

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
• 10884521845923: PillCam (TM) Desktop Software v9.7 Upgrade
• 10884521845916: PillCam (TM) Desktop Software v9.7