Vital Signs™ 545303-HEL

GUDID 10190752111226

300-series ECG Care Cable, 5-lead, AHA, 3 m/ 10 ft

Vyaire Medical Oy

Electrocardiographic lead set, reusable

• Primary Device ID: 10190752111226
• NIH Device Record Key: 04f78804-6445-4e06-95ea-73fd7a3497c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vital Signs™
• Version Model Number: 545303-HEL
• Catalog Number: 545303-HEL
• Company DUNS: 368457563
• Company Name: Vyaire Medical 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: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752111226 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-06-06
• Device Publish Date: 2018-11-23

On-Brand Devices [Vital Signs™]

• 20190752109275: Breathing Circuit, Pediatric, Disposable, 3.75 m/150 in With Manual Bag, 1 L, Gas Sampling Elbow
• 20190752109244: Co-axial Breathing Circuit, Adult, Disposable, 1.5 m/60 in With Gas Sampling Elbow, HMEF 750/S,
• 20190752109206: Patient Circuit, Expandable, Pediatric, Disposable, 3.0 m/120 in With Gas Sampling Elbow, Uni-Fi
• 20190752109190: Co-axial Circuit, Adult, Disposable 1.5 m/60 in With Gas Sampling Elbow, HMEF 750/S and Manual B
• 20190752109183: Co-axial Breathing Circuit, Adult, Disposable, 1.5 m/60 in With Gas Sampling Elbow, HMEF 750, Ma
• 20190752109176: Co-axial Breathing Circuit, Adult, Disposable, 1.8 m/72 in With Gas Sampling Elbow, HMEF 750/S,
• 20190752109169: Breathing Circuit, Expandable, Adult, Disposable, 3.0 m/120 in With Gas Sampling Elbow, Manual B
• 20190752109114: Breathing Circuit, Expandable, Adult, Disposable, 3.0m/120 in With HMEF 750/S, Gas Sampling Elbo
• 20190752109084: Co-axial Breathing Circuit, Adult, Disposable, 1.8m/72 in With Elbow, Manual Bag, 3 L, HMEF 750/
• 20190752109077: Breathing Circuit, Adult, Expandable, Disposable, 3.0m/120 in With Unifilter Junior, Gas Samplin
• 20190752109053: Breathing Circuit, Expandable, Adult, Disposable, 3 m/120 in With HMEF 750/s, Gas Sampling Elbow
• 20190752109046: Breathing Circuit, Expandable, Adult, Disposable, 2.4 m/96 in With HMEF 750/S, Gas Sampling Elbo
• 20190752109008: Breathing Circuit, Expandable, Adult, Disposable, 3.0 m/120 in With Gas Sampling Elbow, Manual B
• 20190752108995: Breathing Circuit, Expandable, Pediatric, Disposable, 1.8 m/72 in With Gas Sampling Elbow, Gas S
• 20190752108988: Breathing Circuit, Expandable, Adult, Disposable, 3.0 m/120 in With HMEF1000, Gas Sampling Elbow
• 20190752109237: Breathing Circuit Components, HMEF Mini/s with Elbow, Disposable
• 20190752109213: Breathing Circuit Components, HMEF 750/S with Elbow, Disposable
• 50190752110760: CAPNOSTAT Pediatric/Infant Airway Adapter, Disposable
• 50190752110753: CAPNOSTAT Adult/Pediatric Airway Adapter, Disposable
• 10190752110731: Vital Signs CAPNOSTAT Pediatric/Infant Airway Adapter, Reusable
• 10190752110724: Vital Signs CAPNOSTAT Adult/Pediatric Airway Adapter, Reusable
• 50190752110708: Sampling Line with Male Luer and Dehumidification Tubing for CapnoFlex Module
• 50190752110692: Sampling Line with Male Luer for CapnoFlex Module
• 50190752110685: Infant/Neonatal Airway Adapter with Dehumidification Tubing for CapnoFlex Module
• 50190752110678: Adult/Pediatric Airway Adapter with Dehumidification Tubing for CapnoFlex Module
• 50190752110661: Infant/Neonatal Airway Adapter for CapnoFlex Module
• 50190752110654: Adult /Pediatric Airway Adapter for CapnoFlex Module
• 50190752110647: Pediatric Oral/Nasal CO2 Sampling with O2 Delivery Cannula for CapnoFlex Module
• 50190752110630: Adult Oral/Nasal CO2 Sampling with O2 Delivery Cannula for CapnoFlex Module
• 50190752110623: Pediatric Oral/Nasal CO2 Sampling Cannula for CapnoFlex Module
• 50190752110616: Adult Oral/Nasal CO Sampling Cannula for CapnoFlex Module
• 50190752110609: Infant/Neonatal Nasal CO2 Sampling with O2 Delivery Cannula for CapnoFlex Module
• 50190752110593: Pediatric Nasal CO2 Sampling with O2 Delivery Cannula for CapnoFlex Module
• 50190752110586: Adult Nasal CO2 Sampling with O2 Delivery Cannula for CapnoFlex Module
• 50190752110579: Infant/Neonatal Nasal CO2 Sampling Cannula for CapnoFlex Module
• 10190752110564: Pediatric Nasal CO2 Sampling Cannula for CapnoFlex Module
• 50190752110555: Adult Nasal CO2 Sampling Cannula for CapnoFlex Module
• 10190752179356: Cardiac Output Care Cable for GE Monitors, 2.7 m/8 ft
• 10190752179349: Cardiac Output Care Cable for GE Monitors, 3.6 m/12 ft
• 10190752179318: Direct Connect Temperature Cable for GE Monitors, 400 Series, Dual, 3.6 m/12 ft
• 10190752179301: Direct Connect Temperature Cable for GE Monitors, 400 Series, Single, 3.6 m/12 ft
• 10190752179295: Temperature Cable for GE Monitors, 400 Series, Single, 0.5 m / 20 in
• 10190752179288: Invasive Blood Pressure Cable, For use with EDWARDS Lifesciences TRUWAVE, Dual, 3.6 m/12 ft
• 10190752179271: Invasive Blood Pressure Cable, For use with EDWARDS LS TRUWAVE, Single, 3.6 m/12 ft
• 10190752179264: Invasive Blood Pressure Cable, For use with ICU Medical TRANSPAC-IV, Dual, 3.6 m/12 ft
• 10190752179257: Invasive Blood Pressure Cable, For use with ICU Medical TRANSPAC-IV, Single, 3.6 m/12 ft
• 10190752179097: Temperature Cable for GE Monitors, 400 Series, Dual, 0.5 m / 20 in
• 10190752179080: Invasive Blood Pressure Cable, For use with Utah/Biotrans, Dual, 3.6 m/12 ft
• 10190752179073: Invasive Blood Pressure Cable, For use with Utah/Biotrans, Single, 3.6 m/12 ft
• 10190752179066: Invasive Blood Pressure Cable, For use with Merit Medical Meritrans DTXPlus, Dual, 3.6 m/12 ft