20554-002

GUDID 10653405000020

ECG LEADWIRES

Conmed Corporation

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable

• Primary Device ID: 10653405000020
• NIH Device Record Key: 16d77244-830c-446d-928e-82d2d4fb98ac
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 20554-002
• Catalog Number: 20554-002
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• 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(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 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10653405000020 [Primary]

FDA Product Code

• IKD: CABLE, ELECTRODE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-06-06
• Device Publish Date: 2016-09-24

Devices Manufactured by Conmed Corporation

• 10653405000020 - NA: 2024-06-06ECG LEADWIRES
• 10653405000020 - NA: 2024-06-06 ECG LEADWIRES
• 10653405004578 - NA: 2024-06-06 5-LEAD COMBINER
• 10653405004608 - NA: 2024-06-06 RE-ORDER TAG
• 10653405004622 - NA: 2024-06-06 ECG CABLES
• 10653405064220 - NA: 2024-06-06 ECG LEADWIRES
• 30845854080751 - PENADAPT: 2024-05-03 PenAdapt Electrosurgical Pencil Adapter 1 ft (30.5cm) tubing
• 30845854061767 - NA: 2024-05-03 EY Tubing Kit 1-3/8 in (35mm) x 6 ft (1.8m) tube and six 2 ft (.6m) tubes with integral wand & sponge guard
• 30845854045798 - CrossFT: 2024-04-26 CrossFT Knotless Biocomposite 4.0 mm Suture Anchor with one 2 mm Hi-Fi Tape (Blue)