Vital Signs™ 545316-HEL

GUDID 10889483585955

Vital Signs™ 300-Series ECG Leadwire, 5-lead, Grabber, IEC, 125 cm/ 49 in & 75 cm/ 30 in

AirLife Finland Oy

Electrocardiographic lead set, reusable

• Primary Device ID: 10889483585955
• NIH Device Record Key: ab50a957-47a0-490a-ac70-dfeda2821a43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vital Signs™
• Version Model Number: 545316-HEL
• Catalog Number: 545316-HEL
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752181144 [Previous]
GS1	10889483585955 [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: true
• Device Is Sterile: false

[10889483585955]

High-level Disinfectant

[10889483585955]

High-level Disinfectant

[10889483585955]

High-level Disinfectant

[10889483585955]

High-level Disinfectant

[10889483585955]

High-level Disinfectant

[10889483585955]

High-level Disinfectant

[10889483585955]

High-level Disinfectant

[10889483585955]

High-level Disinfectant

[10889483585955]

High-level Disinfectant

[10889483585955]

High-level Disinfectant

[10889483585955]

High-level Disinfectant

[10889483585955]

High-level Disinfectant

[10889483585955]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-03
• Device Publish Date: 2025-03-26

On-Brand Devices [Vital Signs™]

• 10190752125667: Reusable Temperature Probes, 400-Series, Skin Probe, 3 m/10 ft.
• 10190752125650: Reusable Temperature Probes, 400-Series, General Purpose Probe, Pediatric, 3 m/10 ft.
• 10190752125643: Reusable Temperature Probes, 400-Series, General Purpose Probe, Adult, 3 m/10 ft.
• 10190752125636: Cardiac output in-line injectate probe for GE monitors, ICU Medical Thermoset, 2.4 m/8 ft
• 10190752125629: Cardiac output in-line injectate probe for GE monitors, BD CritiKit, 0.9 m/3 ft
• 10190752125612: Cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft
• 10190752125605: Cardiac output injectate bath probe for GE monitors, 1.8 m/6 ft
• 10190752125599: Cardiac Output Care Cable for GE Monitors, 2.7 m/8 ft
• 10190752125582: Cardiac Output Care Cable for GE Monitors, 3.6 m/12 ft
• 10190752117051: Diagnostic Cardiology ECG Connector Grabber, IEC, 14/set
• 10190752117044: Diagnostic Cardiology ECG Connector Mactrode™, AHA, 14/set
• 10190752117037: Diagnostic Cardiology ECG Connector Banana, AHA, 14/set
• 10190752116962: Diagnostic Cardiology ECG Connector Grabber, AHA, 10/set
• 10190752116955: Diagnostic Cardiology ECG Connector Mactrode™, AHA, 10/set
• 10190752116948: Diagnostic Cardiology ECG Connector Banana, AHA, 10/set
• 10190752116931: Connector for CAM14 Banana V7 Gray AHA
• 10190752116924: Connector for CAM14 Banana V4R Gray AHA
• 10190752116917: Connector for CAM14 Banana V3R Gray AHA
• 10190752116900: Connector for CAM14 Mactrode™ V7 Gray AHA
• 10190752116894: Connector for CAM14 Mactrode™ V4R Gray AHA
• 10190752116887: Connector for CAM14 Mactrode™ V3R Gray AHA
• 10190752113756: Invasive Blood Pressure Cable, For use with EDWARDS LS TRUWAVE, Dual, 3.6 m/12 ft
• 10190752113749: Invasive Blood Pressure Cable, For use with EDWARDS LS TRUWAVE, Single, 3.6 m/12 ft
• 10190752113732: Invasive Blood Pressure Cable, For use with ICU Medical TRANSPAC-IV, Dual, 3.6 m/12 ft
• 10190752113725: Invasive Blood Pressure Cable, For use with ICU Medical TRANSPAC-IV, Single, 3.6 m/12 ft
• 10190752113718: Invasive Blood Pressure Cable, For use with Utah/Biotrans, Dual, 3.6 m/12 ft
• 10190752113701: Invasive Blood Pressure Cable, For use with Utah/Biotrans, Single, 3.6 m/12 ft
• 10190752113695: Invasive Blood Pressure Cable, For use with Argon, Dual, 3.6 m/12 ft
• 10190752113688: Invasive Blood Pressure Cable, For use with Argon, Single, 3.6 m/12 ft.
• 10190752113671: Invasive Blood Pressure Cable, Dual adapter, 0.3 m/1 ft
• 10190752113664: Direct Connect Temperature Cable for GE Monitors, 400 Series, Dual, 3.6 m
• 10190752113657: Direct Connect Temperature Cable for GE Monitors, 400 Series, Single, 3.6 m
• 10190752113640: Temperature Cable for GE Monitors, 400 Series, Single, 0.5 m / 20 in
• 10190752113633: Temperature Cable for GE Monitors, 400 Series, Dual, 0.5 m / 20 in
• 10190752113565: Cable for CAM14, for MAC5500 , 4.6m / 15ft
• 10190752113558: Cable for CAM14, for CASE , 4.6m / 15ft
• 10190752113541: Cable for CAM14, for MAC5500 , 1.3m / 4.2ft
• 10190752113534: Interconnect Temperature Cable for GE Monitors 400 series, 2.8 m / 9 ft
• 10190752113527: Interconnect Temperature Cable for GE Monitors 400 series, 1.3 m / 4 ft
• 10889483586570: Vital Signs™ Flexible Tube, Disposable
• 10889483585993: Vital Signs™ 300-Series ECG Leadwire, 5-lead, Snap, AHA, 125 cm/ 49 in & 75 cm/ 30 in
• 10889483585979: Vital Signs™ 300-Series ECG Leadwire, 5-lead, Grabber, AHA, 125 cm/ 49 in & 75 cm/ 30 in
• 10889483585955: Vital Signs™ 300-Series ECG Leadwire, 5-lead, Grabber, IEC, 125 cm/ 49 in & 75 cm/ 30 in
• 10889483585948: Vital Signs™ 300-Series ECG Leadwire, 3-lead, Grabber, IEC, 75 cm/ 30 in
• 10889483576328: Vital Signs™ direct connect temperature cable for GE monitors, 400 series, dual, 3.6 m
• 10889483576304: Vital Signs™ direct connect temperature cable for GE monitors, 400 series, single, 3.6 m
• 10889483576298: Vital Signs™ temperature cable for GE monitors, 400 series, single, 0.5 m
• 10889483575796: Vital Signs™ temperature cable for GE monitors, 400 series, dual, 0.5 m
• 10889483573822: Vital Signs™ interconnect temperature cable for GE monitors, 400 series, 2.8 m / 9 ft
• 10889483573815: Vital Signs™ interconnect temperature cable for GE monitors, 400 series, 1.3 m/ 4 ft