Infant Flow 26404-001

GUDID 50190752154023

Infant Flow LP nCPAP Generator without Prongs

VYAIRE MEDICAL, INC.

Respiratory oxygen therapy system

• Primary Device ID: 50190752154023
• NIH Device Record Key: 66745719-50ce-404a-99e2-b1af4b221efe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infant Flow
• Version Model Number: 26404-001
• Catalog Number: 26404-001
• 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: 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: true
• 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	10190752154025 [Primary]
GS1	50190752154023 [Package]; Contains: 10190752154025; Package: Case [10 Units]; In Commercial Distribution

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: 2021-03-15
• Device Publish Date: 2021-03-05

On-Brand Devices [Infant Flow]

• 50190752184495: Infant Flow LP Bonnet & Straps, 36-38 cm
• 50190752184488: Infant Flow LP Bonnent & Straps, 34-36 cm
• 50190752184457: Infant Flow LP Bonnent & Straps, 28-30 cm
• 50190752184440: Infant Flow LP Bonnet & Straps, 26-28 cm
• 50190752154023: Infant Flow LP nCPAP Generator without Prongs
• 50190752151978: Infant Flow LP Nasal Mask - Extra Large
• 50190752151961: Infant Flow LP Nasal Mask - Small
• 50190752151947: Infant Flow LP Nasal Mask - Large
• 50190752151930: Infant Flow LP Nasal Prongs
• 50190752151923: Infant Flow LP Nasal Prongs - Extra Large