SIPAP 27476-001

GUDID 10190752164895

KIT, SIPAP IF, COMP, AUX, NIST, ICONS

VYAIRE MEDICAL, INC.

Neonatal intensive-care ventilator

• Primary Device ID: 10190752164895
• NIH Device Record Key: 1ecd0b39-8766-4fd7-8233-dc54fcea4012
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIPAP
• Version Model Number: 27476-001
• Catalog Number: 27476-001
• Company DUNS: 080456871
• Company Name: VYAIRE MEDICAL, INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752164895 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101643

FDA Product Code

• CBK: Ventilator, continuous, facility use

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: 2021-03-29
• Device Publish Date: 2021-03-19

Devices Manufactured by VYAIRE MEDICAL, INC.

• 10190752187818 - iFlow: 2024-11-13 iFlow 200 S Adult/Pediatric Proximal Flow Sensor
• 50190752187823 - iFlow: 2024-11-13 iFlow 40 S Neonatal/Infant Proximal Flow Sensor
• 50190752200805 - LTV: 2024-11-13 Patient Circuit W/O PEEP, 15mm, SPU, Single Heated Wire, F&P
• 50190752200829 - LTV: 2024-11-13 Patient Circuit W/O PEEP, 22mm, SPU, Dual Heated Wire, F&P
• 10190752201019 - 3100 HFOV: 2024-11-13 Tube Set, Filtered Patient Circuit
• 10190752201118 - LTV: 2024-11-13 Patient Circuit Ventilator Adapter
• 50190752201536 - LTV: 2024-11-13 Patient Circuit, W/ PEEP, 15mm, SPU
• 50190752200751 - LTV: 2024-08-21 Patient Circuit W/O PEEP, 22mm, SPU, Single Heated Wire, F&P