GastriSail GPS40

GUDID 20884521517384

Gastric Positioning System

Covidien LP

Gastric calibration tube, non-sterile
Primary Device ID20884521517384
NIH Device Record Keydd159277-1d34-4750-8873-db010f0bf6d6
Commercial Distribution Discontinuation2019-03-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGastriSail
Version Model NumberGPS40
Catalog NumberGPS40
Company DUNS058614483
Company NameCovidien LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French
Catheter Gauge40 French

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521517387 [Primary]
GS110884521661516 [Package]
Package: PACK [3 Units]
Discontinued: 2019-03-25
Not in Commercial Distribution
GS120884521517384 [Package]
Contains: 10884521517387
Package: CASE [3 Units]
Discontinued: 2019-03-25
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-07-08
Device Publish Date2016-10-17

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20884521084992 - DAR2025-04-21 Catheter Mount
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Trademark Results [GastriSail]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GASTRISAIL
GASTRISAIL
86329365 4757520 Live/Registered
Covidien LP
2014-07-07

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