FDA.reportPublic FDA data

Oxygen Tube

Primary DI
04719872102014
Brand
Oxygen Tube
Company
ENTER MEDICAL CORPORATION
Model
ENT-2023
Device description
Oxygen Tube
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872102014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872102014047198721020144719872102014

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration tubingA length of flexible noninvasive tube, typically a small bore, thick-walled, anti-kink tubing (to prevent blockage) intended for the delivery of a pure oxygen (O2), or an O2 enriched gas, to a mask or nasal cannula (not included), during delivery of dry O2 to the patient. The tubing is typically available in standard coil lengths and is cut by clinical staff to appropriate lengths to create an extension or connecting piece. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658833116
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719872100607RESERVOIRPN-06012023-10-19
04719872101208Seal Rite Mask1202023-10-19
04719872102021Catheter MountPN-20252023-10-19
04719872103028Bubble HumidifierPN-302-012023-10-19
04719872104414Nasal CannulaPN-20132023-10-19
04719872104568reusable resuscitatorENT-10222023-10-19
04719872109631Disposable ResuscitatorENT-10012023-10-19
04719872109853Anaesthetic Face MaskPN-05062023-10-19
047198721088012M TubeENT-20232023-09-28
04719872109501Breathing CircuitENT-20232023-09-28
04719872109532Breathing CircuitENT-20232023-09-28
04719872109723HEAD STRAPENT-20232023-09-28
04719872102007LARYNGOSCOPEENT-20022023-06-19
04719872103929Silicone maskPN-0503-22A2023-06-19
04719872104124Water TrapENT-20132023-06-19
04719872108764Bite BlockPN-6002023-06-19
04719872108788Berman AirwayPN-20012023-06-19
04719872108795Teeth Screw DriverPN-20022023-06-19
04719872101017mada10282015-10-14
04719872101024mada14342015-10-14

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Primary DI, Brand, Company table
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