3100 HFOV

Basic Information

• Brand Name: 3100 HFOV
• Primary DI: 10190752158900
• Version / Model: 11438-PMN
• Catalog Number: 11438-PMN
• Company Name: VYAIRE MEDICAL, INC.
• Labeler DUNS: 080456871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-08
• Public Version: 1
• Public Version Date: 2021-02-16
• Public Version Status: New
• Public Device Record Key: 29ffcbe6-382a-44f3-aea3-0d2a4bfa2d8a

Device Description

Tube Set, Filtered Patient Circuit

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
61833	Inspiratory/expiratory limb respiratory tubing, reusable	A length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and with other separate gas delivery devices (e.g., respiratory mask, connectors). This is a reusable device intended to be cleaned/disinfected prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10190752158900	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P890057	000