FDA.reportPublic FDA data

2M Tube

Primary DI
04719872108801
Brand
2M Tube
Company
ENTER MEDICAL CORPORATION
Model
ENT-2023
Device description
2M 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
BYYTube, Aspirating, Flexible, Connecting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYYTube, Aspirating, Flexible, ConnectingGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872108801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872108801047198721088014719872108801

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). 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
04719872102014Oxygen 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840329830397ASPIRATION TUBINGBLACK & BLACK SURGICAL, INC.BYY2026-07-30
00840329837648ASPIRATION TUBINGBLACK & BLACK SURGICAL, INC.BYY2026-07-30
05060212054630Silicone Tube 0.3mm ID x 0.64mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054654Silicone DCR Tube 1.02mm ID x 2.16mm OD x 40mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054661Silicone Tube 1.02mm ID x 2.16mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054678Silicone Tube 1.02mm ID x 2.16mm OD x 1000mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054685Silicone Tube 1.57mm ID x 3.18mm OD x 250mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054692Silicone Tube 1.57mm ID x 3.18mm OD x 250mm long, two piecesDTR MEDICAL LIMITEDBYY2026-06-10
05060212054715Silicone Tube 1.57mm ID x 3.18mm OD x 450mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054722Silicone Tube 1.57mm ID x 3.18mm OD x 700mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054753Silicone Tube 1.98mm ID x 3.18mm OD x 200mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054791Silicone Tube 2.65mm ID x 4.88mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054814Silicone Tube 3.2mm ID x 6.4mm OD x 200mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054838Silicone Tube 3.2mm ID x 6.4mm OD x 800mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054845Silicone Tube 3.2mm ID x 6.4mm OD 1100mm long- HouseDTR MEDICAL LIMITEDBYY2026-06-10
05060212054876Silicone Tube 4.8mm ID x 7.9mm OD x 150mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054883Silicone Tube 4.8mm ID x 7.9mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054890Silicone Tube 4.8mm ID x 7.9mm OD x 600mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054913Silicone Tube 4.8mm ID x 7.9mm OD x 760mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054944Silicone Tube 4.8mm ID x 7.9mm OD x 1350mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054951Silicone Tube 4.8mm ID x 7.9mm OD x 1500mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054968Silicone Tube 4.8mm ID x 7.9mm OD x 1750mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055002Silicone Tube 5.0mm ID x 8.3mm OD x 600mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055026Silicone Tube 5.0mm ID x 8.3mm OD x 1500mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055095Silicone Tube 6.4mm ID x 9.5mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055118Silicone Tube 6.4mm ID x 9.5mm OD x 700mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055125Silicone Tube 6.4mm ID x 9.5mm OD x 1000mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060411983229Sterile Silicone Tube 1.57 ID x 2.41 OD x 400mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060411984066Silicone Tube 3.2mm ID x 6.4mm OD x 400mm longDTR MEDICAL LIMITEDBYY2026-06-10
10192253042894ArgyleCardinal Health 200, LLCBYY2025-02-27