N/A

GUDID 20190752135670

T-Piece Neonatal Patient Circuit Kit, Disposable

Vyaire Medical Oy

Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use

• Primary Device ID: 20190752135670
• NIH Device Record Key: 6c75a748-ef6a-4eef-b90d-8a077d3ea46d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: M1091316VS
• Company DUNS: 368457563
• Company Name: Vyaire Medical Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• 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	10190752135673 [Primary]
GS1	20190752135670 [Package]; Contains: 10190752135673; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093913

FDA Product Code

• BTL: Ventilator, Emergency, Powered (Resuscitator)

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: 2019-11-27
• Device Publish Date: 2019-04-15

On-Brand Devices [N/A]

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• 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/
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• 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