FDA.reportPublic FDA data

HYGITECH

Primary DI
03615140001991
Brand
HYGITECH
Company
HYGITECH
Model
HY-12014
Catalog number
HY-12014
Device description
Surgical aspiration set compatible with all aspiration systems and composed of: a surgical cannula a filter for collecting bone fragments a 2m PVC tubeSupplied with a universal adaptor for aspiration systems.
Published
2020-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EBRUnit, Suction Operatory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBRUnit, Suction OperatoryDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615140002004PackageGS15In Commercial Distribution
03615140002011PackageGS116In Commercial Distribution
03615140001991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615140002004036151400020043615140002004
03615140002011036151400020113615140002011
03615140001991036151400019913615140001991

GMDN Terms#

Term, Definition table
TermDefinition
Airway suction catheterA flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device.

Regulatory Flags#

DUNS number
279456896
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03615140002875HYGITECHHY-064HY-0642020-12-15
03615140002899HYGITECHHY-066HY-0662020-12-15
03615140003247HYGITECHHY-50013HY-500132020-12-15
03615140003568HYGITECHHY-50018HY-500182020-12-15
03615140003612HYGITECHHY-50016HY-500162020-12-15
03615140003728HYGITECHHY1-630HY1-6302020-10-13
03615140000116HYGITECHHY-90078HY-900782020-12-14
03615140000307HYGITECHHY-057HY-0572020-12-15
03615140000321HYGITECHHY-055HY-0552020-12-15
03615140002721HYGITECHHY-05702HY-057022020-12-15
03615140002837HYGITECHHY-060HY-0602020-12-15
03615140002851HYGITECHHY-062HY-0622020-12-15
03615140002561HYGITECHHY-130012HY-1300122020-11-24
03615140002592HYGITECHHY-130025HY-1300252020-12-15
03615140004534HYGITECHHY-130014HY-1300142020-12-16
03615140003261HYGITECHHY-50015HY-500152020-12-15
03615140003094HYGITECHHY-525HY-5252020-11-25
03615140003124HYGITECHHY-604HY-6042020-11-25
03615140003155HYGITECHHY-607HY-6072020-11-25
03615140003186HYGITECHHY-60033HY-600332020-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841709122286MidmarkMIDMARK CORPORATIONEBR2026-02-20
06971119541910Suction machineGuangdong JINME Medical Technology Co., Ltd.EBR2025-07-15
07898938244220MaquiraMaquira Industria de Produtos Odontologicos S/AEBR2024-08-07
07898938244237MaquiraMaquira Industria de Produtos Odontologicos S/AEBR2024-08-07
07898938244732MaquiraMaquira Industria de Produtos Odontologicos S/AEBR2024-08-07
00810032660710Isolite, i2ZYRIS, INC.EBR2024-04-19
00810032660758Isolite, i2ZYRIS, INC.EBR2024-04-19
00810032660765Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660772Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660789Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660796Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660802Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660819Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660826Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660833Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660840Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660857Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660864Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660871Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660888Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660901Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660925Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660932Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660949Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660956Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660963Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660970IsovacZYRIS, INC.EBR2024-04-19
00810032660987Anterior MouthpieceZYRIS, INC.EBR2024-04-19
00810032661007Anterior Hose KitZYRIS, INC.EBR2024-04-19
00810032661014Operating Room AdapterZYRIS, INC.EBR2024-04-19