Flexon

GUDID 20884521103792

Multifilament Temporary Cardiac Pacing Lead

Covidien LP

Transthoracic pacing lead

• Primary Device ID: 20884521103792
• NIH Device Record Key: 65ef88e1-3c4b-46cc-94b3-dc2ff71ea18a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexon
• Version Model Number: 88862617-53
• 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

Device Dimensions

• Length: 24 Inch
• Device Size Text, specify: 0
• Length: 24 Inch
• Device Size Text, specify: 0
• Length: 24 Inch
• Device Size Text, specify: 0
• Length: 24 Inch
• Device Size Text, specify: 0
• Length: 24 Inch
• Device Size Text, specify: 0
• Length: 24 Inch
• Device Size Text, specify: 0
• Length: 24 Inch
• Device Size Text, specify: 0
• Length: 24 Inch
• Device Size Text, specify: 0
• Length: 24 Inch
• Device Size Text, specify: 0
• Length: 24 Inch
• Device Size Text, specify: 0
• Length: 24 Inch
• Device Size Text, specify: 0
• Length: 24 Inch
• Device Size Text, specify: 0
• Length: 24 Inch
• Device Size Text, specify: 0
• Length: 24 Inch
• Device Size Text, specify: 0
• Length: 24 Inch
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521103795 [Primary]
GS1	20884521103792 [Package]; Contains: 10884521103795; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955722

FDA Product Code

• LDF: ELECTRODE, PACEMAKER, TEMPORARY

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: 2024-05-20
• Device Publish Date: 2015-08-31

On-Brand Devices [Flexon]

• 20884521103747: Multifilament Temporary Cardiac Pacing Lead
• 20884521757575: Multifilament Temporary Cardiac Pacing Lead
• 20884521757568: Multifilament Temporary Cardiac Pacing Lead
• 20884521757551: Multifilament Temporary Cardiac Pacing Lead
• 20884521757544: Multifilament Temporary Cardiac Pacing Lead
• 20884521103808: Multifilament Temporary Cardiac Pacing Lead
• 20884521103792: Multifilament Temporary Cardiac Pacing Lead
• 20884521103785: Multifilament Temporary Cardiac Pacing Lead
• 20884521103778: Multifilament Temporary Cardiac Pacing Lead
• 20884521103761: Multifilament Temporary Cardiac Pacing Lead
• 20884521103754: Multifilament Temporary Cardiac Pacing Lead
• 20884521103730: Multifilament Temporary Cardiac Pacing Lead
• 20884521103716: Multifilament Temporary Cardiac Pacing Lead