ApexPro™ 394111-501

GUDID 10889483581384

ECG Leadwire Set, 3-Lead for ApexPro™ FH, Grabber, AHA, 75 cm/ 29 in

AirLife Finland Oy

Electrocardiographic lead set, reusable

• Primary Device ID: 10889483581384
• NIH Device Record Key: c5c7bda9-9dea-4862-a63f-31b7eed9ac59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ApexPro™
• Version Model Number: 394111-501
• Catalog Number: 394111-501
• Company DUNS: 368457563
• Company Name: AirLife Finland Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752138162 [Previous]
GS1	10889483581384 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980582

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

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: 2025-04-07
• Device Publish Date: 2025-03-28

On-Brand Devices [ApexPro™]

• 10889483581438: ECG Leadwire Set, 6-Lead for ApexPro™ FH, Snap, AHA, 75 cm/ 29 in
• 10889483581421: ECG Leadwire Set, 5-Lead for ApexPro™ FH, Snap, AHA, 75 cm/ 29 in
• 10889483581414: ECG Leadwire Set, 3-Lead for ApexPro™ FH, Snap, AHA, 75 cm/ 29 in
• 10889483581407: ECG Leadwire Set, 6-Lead for ApexPro™ FH, Grabber, AHA, 75 cm/ 29 in
• 10889483581391: ECG Leadwire Set, 5-Lead for ApexPro™ FH, Grabber, AHA, 75 cm/ 29 in
• 10889483581384: ECG Leadwire Set, 3-Lead for ApexPro™ FH, Grabber, AHA, 75 cm/ 29 in