HET 180-1022

GUDID 20884521511139

Bipolar Forceps

Covidien LP

Tracheoesophageal speech valve, indwelling, sterile

• Primary Device ID: 20884521511139
• NIH Device Record Key: 65b53ff6-a41b-4c60-b8a7-0bccceb64272
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HET
• Version Model Number: 180-1022
• Catalog Number: 180-1022
• 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
• 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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521511132 [Primary]
GS1	20884521511139 [Package]; Contains: 10884521511132; Package: CASE [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140422

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-09
• Device Publish Date: 2016-09-24

On-Brand Devices [HET]

• 10884521511170: Reusable Cable
• 10884521511149: Temperature Monitor
• 20884521511139: Bipolar Forceps
• 10884521539792: Reusable Cable For Use with HET Temperature Monitor
• 10884521511156: Temperature Monitor
• 10884521791121: HET Reusable Cable