Emprint HP CAGENHP

GUDID 10884521781276

Ablation Generator with Thermosphere Technology 150W

Covidien LP

Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system

• Primary Device ID: 10884521781276
• NIH Device Record Key: bd2e9e73-b797-4793-abc1-80c766887f63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Emprint HP
• Version Model Number: CAGENHP
• Catalog Number: CAGENHP
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521781276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200796

FDA Product Code

• NEY: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

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: 2020-11-02
• Device Publish Date: 2020-10-24

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• 10884521781276: Ablation Generator with Thermosphere Technology 150W
• 10884521806443: Ablation Cart