FDA.reportPublic FDA data

Hayek RTX

Primary DI
05060526070005
Brand
Hayek RTX
Company
UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED
Model
01
Device description
The United Hayek RTX Ventilator 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
2017-12-18
Public version status
Update
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
05060526070005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060526070005050605260700055060526070005

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
05060526070487Hayek OscillatorHOSC-012023-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060526070487Hayek OscillatorUNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITEDBYT2023-11-22