FDA.reportPublic FDA data

Oxymixer XL Low Flow

Primary DI
04251411700775
Brand
Oxymixer XL Low Flow
Company
DEHAS Medical Systems GmbH
Model
XL Low Flow
Device description
Oxymixer XL blender Low Flow
Published
2023-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BZRMixer, Breathing Gases, Anesthesia Inhalation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221494000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221494000Quality Mix Blender, OxymixerDehas Medical Systems GmbH2023-01-23BZR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251411700775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251411700775042514117007754251411700775

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen/air/nitrous oxide breathing gas mixerAn independent mechanical device designed for accurate mixing of oxygen (O2) and air or O2 and nitrous oxide (N2O) in pre-set concentrations appropriated for breathing. The mixer receives all three gases from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. It usually delivers the gases with adjustable N2O or air concentrations and ensures a minimum O2 level to the patient through a face mask, mouthpiece, or endotracheal (ET) tube. It is used to improve O2 uptake and/or relieve pain throughout a hospital, during dental procedures, or in obstetrics during labour. It may also be attached to ventilators or anaesthesia machines.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
343728657
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251411706029QualityREGDM-AD-CO2-NIST-DIN-KDM-AD-CO2-NIST-DIN-K2024-07-24
04251411703691Quality Connect HDUI024HD-CO2-716-W21-0,552023-01-02
04251411703714Quality Connect HDUI025HD-CO2-716-W21-1,022023-01-02
04251411703721Quality Connect HDUI026HD-CO2-716-PIN-0,552023-01-02
04251411703745Quality Connect HDUI027HD-CO2-716-PIN-1,022023-01-02
04251411703769Quality Connect HDUI028HD-CO2-716-ISO-1,022023-01-02
04251411703776Quality ConnectUI021DIN-CO2-ZGV-716-1,502023-01-02
04251411703783Quality ConnectUI022DIN-CO2-ZGV-716-3,002023-01-02
04251411703790Quality ConnectUI020DISS-CO2-ZGV-716-1,502023-01-02
04251411703806Quality ConnectUI023DIN-CO2-ZGV-716-6,002023-01-02
04251411701833Quality Connect DIN-CO2-NIST-NIST-1,5DIN-CO2-NIST-NIST1,52024-04-16
04251411701840Quality ConnectDIN-CO2-ZGV-NIST-1,5DIN-CO2-ZGVNIST1,52024-04-16
04251411703141Quality ConnectNF-CO2-ZGV-NIST-5,0NF-CO2-ZGV-NIST5,02024-04-16
04251411707200Quality ConnectRW-CO2-ZGV-NIST-5,0RW-CO2-ZGV-NIST-5,02024-04-16
04251411705879QualityREGDM-DIN6-MS-NIST-CO22024-04-08
04251411705886QualityREGDM-PIN-MS-NIST-CO2DM-PIN-MS-NIST-CO22024-04-08
04251411705893QualityREGDM-ISO-MS-NIST-CO2DM-ISO-MS-NIST-CO22024-04-08
04251411700010Oxymixer High Flow SETHigh Flow SETMP042012023-02-17
04251411700027Oxymixer Low Flow SETLow Flow SETMP042032023-02-17
04251411700928Oxymixer Low Flow 15LPMLow Flow 15LPMMP042292023-02-17

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