3100A HFOV

Basic Information

• Brand Name: 3100A HFOV
• Primary DI: 10846446003192
• Version / Model: 11518-850S
• Catalog Number: 11518-850S
• Company Name: Carefusion Corporation
• Labeler DUNS: 830432451
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 4
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: a97f3c75-20bd-49b1-8a20-5629b9bb4e48

Device Description

BOXED PATIENT CIRCUIT ASSY, 31A, FILTERED, 850S

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LSZ	Ventilator, High Frequency	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
37706	Ventilator breathing circuit, single-use	An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10846446003192	GS1
Unit of Use	00846446003195	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]