Bravo FGS-0313

GUDID 07290101361688

pH capsule delivery dev, 1-pk

Covidien LP

Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system Gastrointestinal telemetric monitoring system

• Primary Device ID: 07290101361688
• NIH Device Record Key: ae7ba24e-a407-4114-aea3-f4cc099c7100
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bravo
• Version Model Number: FGS-0313
• Catalog Number: FGS-0313
• 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
• 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
• 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

• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290101361688 [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

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• 07290101361695: pH capsule delivery dev, 5-pk
• 07290101361688: pH capsule delivery dev, 1-pk
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