N/A 394111-501

GUDID 10190752138162

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

Vyaire Medical Oy

Electrocardiographic lead set, reusable

• Primary Device ID: 10190752138162
• NIH Device Record Key: 2a64977f-f6dd-474b-9bd0-dcafe57cdcf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 394111-501
• Catalog Number: 394111-501
• 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
• Phone: 1-833-327-3284
• Email: customersupport@vyaire.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
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752138162 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-21
• Device Publish Date: 2019-06-13

On-Brand Devices [N/A]

• 20190752135694: T-Piece Neonatal Patient Circuit Kit, Disposable
• 20190752135687: T-Piece Neonatal Patient Circuit Kit, Disposable
• 20190752135670: T-Piece Neonatal Patient Circuit Kit, Disposable
• 10190752138216: ECG Leadwire Set, 6-Lead for ApexPro™ FH, Snap, AHA, 75 cm/ 29 in
• 10190752138209: ECG Leadwire Set, 5-Lead for ApexPro™ FH, Snap, AHA, 75 cm/ 29 in
• 10190752138193: ECG Leadwire Set, 3-Lead for ApexPro™ FH, Snap, AHA, 75 cm/ 29 in
• 10190752138186: ECG Leadwire Set, 6-Lead for ApexPro™ FH, Grabber, AHA, 75 cm/ 29 in
• 10190752138179: ECG Leadwire Set, 5-Lead for ApexPro™ FH, Grabber, AHA, 75 cm/ 29 in
• 10190752138162: ECG Leadwire Set, 3-Lead for ApexPro™ FH, Grabber, AHA, 75 cm/ 29 in
• 20190752145334: Leg Attachment Pad for Corometrics; Fetal Scalp Electrode Cable
• 10190752180024: ECG Leadwire, DIN, Radiolucent 5-lead, Grabber, AHA, 150 cm/59 in
• 20190752143835: Intratracheal Pressure Sensor
• 10190752181410: Compatibility ECG Care Cable, from 300-Series Leadwire Set to Multi-Link™, 3/5-Lead, AHA, 3 m/
• 50190752160437: MRI Extension Tubing Set-Patient Breathing Circuit for iVent™ 201
• 50190752148633: Patient Breathing Circuit for iVent™ 201, 1.8 m/6 ft., Disposable
• 50190752148626: Patient Breathing Circuit for iVent™ 201, 1.8 m/6 ft., Disposable
• 10190752145320: Patient Breathing Circuit for iVent™ 201, 1.8 m/6 ft, Disposable
• 10190752145313: Y-piece Flow Sensor for iVent™ 201, Disposable
• 50190752145304: Patient Breathing Circuit for iVent™ 201, 1.8 m/6 ft,Disposable
• 10190752129351: Patient Breathing Circuit for iVent™ 201, 4 m/ 13 ft, Disposable
• 10190752125711: Patient Breathing Circuit for iVent™ 201, 4 m/ 13 ft, Disposable
• 10190752110441: Compatibility ECG Care Cable, from 300-Series Leadwire Set to Multi-Link™, 3/5-Lead, AHA, 3 m/