Infant Flow™ 777010

GUDID 50190752184402

Infant Flow LP Bonnet & Straps, 18-20 cm

VYAIRE MEDICAL, INC.

Respiratory oxygen therapy system

• Primary Device ID: 50190752184402
• NIH Device Record Key: cf0090fd-5a73-46e8-8bc6-ee0909aaeb0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infant Flow™
• Version Model Number: 777010
• Catalog Number: 777010
• 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: true
• 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
• 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	10190752184404 [Primary]
GS1	50190752184402 [Package]; Contains: 10190752184404; 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: 2021-03-22
• Device Publish Date: 2021-03-12

On-Brand Devices [Infant Flow™]

• 50190752184532: Infant Flow LP Headgear, 24-28cm
• 50190752184525: Infant Flow LP Headgear, 21-26cm
• 50190752184501: Infant Flow LP Headgear, 32-37 cm
• 50190752184471: Infant Flow LP Bonnet & Straps, 32-34 cm
• 50190752184143: Infant Flow LP nCPAP Generator Set + Patient Circuit
• 50190752156539: Infant Flow LP nCPAP Generator Set
• 20190752152783: Infant Flow LP nCPAP Generator Set + Patient Circuit
• 50190752152685: Infant Flow LP nCPAP Generator without Prongs
• 50190752151985: Infant Flow LP Nasal Mask - Extra Small
• 50190752151893: Infant Flow LP Nasal Prongs - Large
• 50190752184556: Infant Flow LP Headgear, 17-21 cm
• 50190752184549: Infant Flow LP Headgear, 37-42 cm
• 50190752184518: Infant Flow LP Headgear, 26-32 cm
• 50190752184464: Infant Flow LP Bonnet & Straps, 30-32 cm
• 50190752184433: Infant Flow LP Bonnet & Straps, 24-26 cm
• 50190752184419: Infant Flow LP Bonnet & Straps, 20-22 cm
• 50190752184402: Infant Flow LP Bonnet & Straps, 18-20 cm
• 50190752151954: Infant Flow LP Nasal Mask
• 50190752151916: Infant Flow LP Nasal Prongs
• 50190752151909: Infant Flow LP Nasal Prongs