3100 HFOV 12152

GUDID 20846446003335

ASSY, EXPIRATORY FILTER, BOXED

Carefusion Corporation

Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator

• Primary Device ID: 20846446003335
• NIH Device Record Key: 5393f0d3-8317-4d93-a6d4-ba590e8e2e10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3100 HFOV
• Version Model Number: 12152
• Catalog Number: 12152
• Company DUNS: 830432451
• Company Name: Carefusion Corporation
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 1-800-231-2466
• Email: support.smcvent.us@carefusion.
• Phone: 1-800-231-2466
• Email: support.smcvent.us@carefusion.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846446003331 [Unit of Use]
GS1	20846446003335 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-24

On-Brand Devices [3100 HFOV]

• 20846446003410: CAP/DIAPHRAGM SET, BOX OF 4, 3100A/B
• 20846446003403: BELLOWS/WATER TRAP BOX4
• 20846446003335: ASSY, EXPIRATORY FILTER, BOXED
• 10846446003574: TUBE SET, NON-FILTERED CIRCUIT