Infant Flow 675-CFG-001

GUDID 10846446061895

Infant Flow Ventilator (legacy)

Carefusion Corporation

Neonatal intensive-care ventilator

• Primary Device ID: 10846446061895
• NIH Device Record Key: c4963cc1-13ca-4093-92bb-7e8f21a83609
• Commercial Distribution Discontinuation: 2022-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Infant Flow
• Version Model Number: 675-CFG-001
• Catalog Number: 675-CFG-001
• Company DUNS: 830432451
• Company Name: Carefusion Corporation
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: 800.231.2466
• Email: support.smcvent.us@carefusion.com
• Phone: 800.231.2466
• Email: support.smcvent.us@carefusion.com
• Phone: 800.231.2466
• Email: support.smcvent.us@carefusion.com
• Phone: 800.231.2466
• Email: support.smcvent.us@carefusion.com
• Phone: 800.231.2466
• Email: support.smcvent.us@carefusion.com
• Phone: 800.231.2466
• Email: support.smcvent.us@carefusion.com
• Phone: 800.231.2466
• Email: support.smcvent.us@carefusion.com
• Phone: 800.231.2466
• Email: support.smcvent.us@carefusion.com
• Phone: 800.231.2466
• Email: support.smcvent.us@carefusion.com
• Phone: 800.231.2466
• Email: support.smcvent.us@carefusion.com
• Phone: 800.231.2466
• Email: support.smcvent.us@carefusion.com
• Phone: 800.231.2466
• Email: support.smcvent.us@carefusion.com
• Phone: 800.231.2466
• Email: support.smcvent.us@carefusion.com
• Phone: 800.231.2466
• Email: support.smcvent.us@carefusion.com
• Phone: 800.231.2466
• Email: support.smcvent.us@carefusion.com
• Phone: 800.231.2466
• Email: support.smcvent.us@carefusion.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846446061895 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-06-06
• Device Publish Date: 2017-05-01

On-Brand Devices [Infant Flow]

• 70846446005907: Circuit /LP Gen/No Prongs/ F&P 730 & 850 (Box/20)
• 70846446005891: Circuit /LP Gen/No Prongs/ F&P 730 & 850 (Box/10)
• 70846446004757: BONNET 10 PACK SIZE 6 INFANT FLOW
• 20846446004363: PATIENT CKT/GEN ASSY,BX 20,INFANT FLOW 730
• 10846446063394: Infant Flow Configured Mobile Stand
• 10846446061895: Infant Flow Ventilator (legacy)