3100A/B 22151-801

GUDID 10846446005776

3100A Ventilator 3rd Edition

Carefusion Corporation

Stationary electric high-frequency ventilator

• Primary Device ID: 10846446005776
• NIH Device Record Key: e82396d2-44c7-4194-ae4e-2270a1b76612
• Commercial Distribution Discontinuation: 2022-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 3100A/B
• Version Model Number: 22151-801
• Catalog Number: 22151-801
• 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
• 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	10846446005776 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P890057

FDA Product Code

• LSZ: Ventilator, High Frequency

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: 2024-05-27
• Device Publish Date: 2017-05-01

On-Brand Devices [3100A/B]

• 10846446005868: 3100B Ventilator 3rd Edition
• 10846446005776: 3100A Ventilator 3rd Edition