Continuous Ventilator

Basic Information

• Brand Name: Continuous Ventilator
• Primary DI: 17290013641950
• Version / Model: V200-0001-PKU
• Company Name: FLIGHT MEDICAL INNOVATIONS LTD
• Labeler DUNS: 600023576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-06
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 31458e82-8abb-4151-91ab-1a563a8914f8

Device Description

F60T SL Sym With Interna

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: No
• 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
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	868.5895	2
NOU	Continuous, Ventilator, Home Use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34851	Anaesthesia ventilator	A mains electricity (AC-powered) stand-alone, automatic cycling device used to assist and control alveolar ventilation during general anaesthesia, and is compatible with inhaled anaesthetic agents. It has fewer functions and is less complex to operate than an intensive care ventilator, but adequately meets the patient's ventilation needs for oxygen (O2) and carbon dioxide (CO2) exchange to maintain normal blood gas concentrations. The device provides a mechanical means to deliver the breathing gas to the patient in a controlled pattern, and is equipped with alarms to warn of changes in respiration or the onset of unsafe operating conditions.	No	Active
36289	Transport electric ventilator	An electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17290013641950	GS1

Premarket Submissions

Submission Number	Supplement Number
K143035	000