Hayek Oscillator

Primary DI
05060526070487
Brand
Hayek Oscillator
Company
UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED
Model
HOSC-01
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.
Published
2023-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BYTVentilator, External Body, Negative Pressure, Adult (Cuirass)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYTVentilator, External Body, Negative Pressure, Adult (Cuirass)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082657000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082657000RTX RESPIRATORMedivent Limited2008-10-08BYT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060526070487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060526070487050605260704875060526070487

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure ventilatorAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
211319456
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060526070005Hayek RTX012017-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060526070005Hayek RTXUNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITEDBYT2017-12-18