GastriSail GPS36

GUDID 20884521517377

Gastric Positioning System

Covidien LP

Gastric calibration tube

• Primary Device ID: 20884521517377
• NIH Device Record Key: 2c8f706e-17e9-4b91-a82f-674c27d75e9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GastriSail
• Version Model Number: GPS36
• Catalog Number: GPS36
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: 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

Device Dimensions

• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521517370 [Primary]
GS1	10884521661509 [Package]; Contains: 10884521517370; Package: PACK_OR_INNER_PACK [9 Units]; In Commercial Distribution
GS1	20884521517377 [Package]; Contains: 10884521517370; Package: CASE [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143088

FDA Product Code

• KNT: TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2025-06-13
• Device Publish Date: 2016-10-19

On-Brand Devices [GastriSail]

• 20884521517384: Gastric Positioning System
• 20884521517377: Gastric Positioning System