PROFILE 3500-050

GUDID 20653405056017

PROFILE FOAM 50 ADGEL

Conmed Corporation

Electrocardiographic electrode, single-use

• Primary Device ID: 20653405056017
• NIH Device Record Key: 46892f2f-e6c3-47b4-96e0-9811c896e565
• Commercial Distribution Discontinuation: 2023-02-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PROFILE
• Version Model Number: 3500-050
• Catalog Number: 3500-050
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 1000
• 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(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 35 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405056013 [Unit of Use]
GS1	10653405056010 [Primary]
GS1	20653405056017 [Package]; Contains: 10653405056010; Package: [1000 Units]; Discontinued: 2023-02-24; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091856

FDA Product Code

• DRX: Electrode, electrocardiograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-02-24
• Device Publish Date: 2016-09-24

On-Brand Devices [PROFILE]

• 20653405056017: PROFILE FOAM 50 ADGEL
• 20653405056024: PROFILE TAPE 50 ADGEL