FGS-0303

GUDID 07290101361299

Buffer, pH 1.07, 500 ml

Given Imaging, Inc.

Gastrointestinal telemetric monitoring system

• Primary Device ID: 07290101361299
• NIH Device Record Key: 6840644f-59b0-4aee-8565-cbd9ea965b14
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: FGS-0303
• Catalog Number: FGS-0303
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290101361299 [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.

• 07290110361068 - GIFD: 2020-01-17 PillCam sensor belt, DR3 C2 SBC
• 04260167480954 - ManoScan: 2019-11-08 AR 3D Probe
• 04260167480961 - ManoScan: 2019-11-08 ESO Catheter, SD Regular
• 04260167482422 - ManoScan: 2019-11-08 ESO 3D Catheter
• 04260167482439 - ManoScan: 2019-11-08 ESO With Extended Tip
• 04260167482446 - ManoScan: 2019-11-08 ESO Z Catheter
• 04260167482453 - ManoScan: 2019-11-08 ESO Catheter, SD Small
• 04260167482460 - ManoScan: 2019-11-08 AR Catheter, Small