N/A M1045564

GUDID 20190752143835

Intratracheal Pressure Sensor

Vyaire Medical Oy

Tracheal pressure catheter Tracheal pressure catheter Tracheal pressure catheter Tracheal pressure catheter Tracheal pressure catheter Tracheal pressure catheter Tracheal pressure catheter Tracheal pressure catheter Tracheal pressure catheter Tracheal pressure catheter Tracheal pressure catheter Tracheal pressure catheter Tracheal pressure catheter Tracheal pressure catheter Tracheal pressure catheter

• Primary Device ID: 20190752143835
• NIH Device Record Key: 68bc68cb-46ed-4068-bb2e-a8bf4c8956bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: M1045564
• Catalog Number: M1045564
• Company DUNS: 368457563
• Company Name: Vyaire Medical Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: +1-833-327-3284
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752143838 [Primary]
GS1	20190752143835 [Package]; Contains: 10190752143838; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• BXO: Transducer, Gas Pressure

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-23
• Device Publish Date: 2020-12-15

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