Hayek Oscillator

Basic Information

• Brand Name: Hayek Oscillator
• Primary DI: 05060526070487
• Version / Model: HOSC-01
• Company Name: UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED
• Labeler DUNS: 211319456
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-22
• Public Version: 1
• Public Version Date: 2023-11-30
• Public Version Status: New
• Public Device Record Key: c4b5841e-4f20-454b-8f4e-9ee5ab6460f9

Device Description

The Hayek Oscillator is a non-invasive, biphasic, cuirass ventilator which works on the principle of applying pressure around the body to create chest movement outward for inhalation and inward for exhalation. Biphasic Cuirass Ventilation (BCV) is an established method of non-invasive ventilator treatment.

Device Characteristics

• Single Use: No
• 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: 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
BYT	Ventilator, External Body, Negative Pressure, Adult (Cuirass)	Anesthesiology	868.5935	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17877	Negative-pressure ventilator	An automatic cycling machine used to assist or control alveolar respiration that exerts a negative pressure on the external surface of the chest wall, expanding the chest and moving air into the lungs. The two versions of the device are: 1) a rigid container enclosing all of a patient's body below the neck (i.e., an iron lung); or 2) a wearable shell (a cuirass) where only the thoracoabdominal region is enclosed. In both variants, the pressure inside the container is reduced relative to the atmospheric pressure at the patient's mouth and/or nose.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060526070487	GS1

Premarket Submissions

Submission Number	Supplement Number
K082657	000