N/A M1045564

GUDID 20190752143835

Intratracheal Pressure Sensor

Vyaire Medical Oy

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
• 10190752110441: Compatibility ECG Care Cable, from 300-Series Leadwire Set to Multi-Link™, 3/5-Lead, AHA, 3 m/