Infant Flow SiPAP 27472-001

GUDID 10190752164888

KIT, SIPAP IF, PLUS, AUX, NIST, ICONS

VYAIRE MEDICAL, INC.

Neonatal intensive-care ventilator

• Primary Device ID: 10190752164888
• NIH Device Record Key: c897e890-5dca-4801-858b-4fd17c695a3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infant Flow SiPAP
• Version Model Number: 27472-001
• Catalog Number: 27472-001
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752164888 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031745

FDA Product Code

• BZD: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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: 2021-03-17
• Device Publish Date: 2021-03-09

On-Brand Devices [Infant Flow SiPAP]

• 10190752164888: KIT, SIPAP IF, PLUS, AUX, NIST, ICONS
• 10190752164864: KIT,SIPAP,IF,COMP,AUX,MDISS,ENGLISH
• 10190752161948: KIT, SIPAP IF, COMP, AUX, MDISS, ICONS
• 10190752161931: KIT, SIPAP IF, COMP, AUX, SIS, ENGLISH
• 10190752161924: KIT,SIPAP,IF,COMP,AUX,FDISS,ENGLISH
• 10190752161917: KIT, SIPAP, IF, PLUS, AUX, MDISS, ENGLISH
• 10190752164871: KIT, SIPAP IF, COMP, AUX, NIST, ENGLISH