Hayek Oscillator

GUDID 05060526070487

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.

UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED

Negative-pressure ventilator Negative-pressure ventilator Negative-pressure ventilator Negative-pressure ventilator Negative-pressure ventilator Negative-pressure ventilator Negative-pressure ventilator Negative-pressure ventilator Negative-pressure ventilator Negative-pressure ventilator Negative-pressure ventilator Negative-pressure ventilator Negative-pressure ventilator Negative-pressure ventilator Negative-pressure ventilator Negative-pressure ventilator Negative-pressure ventilator

• Primary Device ID: 05060526070487
• NIH Device Record Key: c4b5841e-4f20-454b-8f4e-9ee5ab6460f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hayek Oscillator
• Version Model Number: HOSC-01
• Company DUNS: 211319456
• Company Name: UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060526070487 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082657

FDA Product Code

• BYT: Ventilator, External Body, Negative Pressure, Adult (Cuirass)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-30
• Device Publish Date: 2023-11-22

Devices Manufactured by UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED

• 05060526070487 - Hayek Oscillator: 2023-11-30The 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.
• 05060526070487 - Hayek Oscillator: 2023-11-30 The Hayek Oscillator is a non-invasive, biphasic, cuirass ventilator which works on the principle of applying pressure around th
• 05060526070005 - Hayek RTX: 2018-07-06 The United Hayek RTX Ventilator is a non-invasive, biphasic, cuirass ventilator which works on the principle of applying pressur