FGS-0302

GUDID 07290101361282

Buffer, pH 7.01, 500 ml

Given Imaging, Inc.

Gastrointestinal telemetric monitoring system

• Primary Device ID: 07290101361282
• NIH Device Record Key: 2522913f-79fa-4362-99d4-1a7e0cfe341b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: FGS-0302
• Catalog Number: FGS-0302
• 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: 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
• 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
• 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
• 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	07290101361282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102543

FDA Product Code

• FFT: Electrode, pH, stomach

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: 2018-10-01
• Device Publish Date: 2018-08-29

Devices Manufactured by Given Imaging, Inc.

• 10884521855441 - ManoScan: 2025-08-29 GIFD WS PC, With SW
• 10884521853317 - ManoScan: 2025-02-03 Manoscan Cart
• 20884521845845 - PillCam Genius: 2024-12-09 SB Capsule Endoscopy Kit
• 10884521846975 - PillCam Genius: 2024-12-09 PillCam Genius Sync Agent, off-line
• 10884521845831 - PillCam Genius: 2024-11-22 PillCam Genius SB Capsule Endoscopy Kit
• 10884521845916 - PillCam: 2024-11-22 PillCam (TM) Desktop Software v9.7
• 10884521845923 - PillCam: 2024-11-22 PillCam (TM) Desktop Software v9.7 Upgrade
• 07290110361068 - GIFD: 2020-01-17 PillCam sensor belt, DR3 C2 SBC