FDA.reportPublic FDA data

Suction Tube

Primary DI
00840199507177
Brand
Suction Tube
Company
KOROS U.S.A., INC.
Model
7218-50
Catalog number
7218-50
Device description
Black Suction Lumbar Tube with Cleaning Stylette 4mm Wide, 9" Depth With Cleaner, 13" 32cm Total Length
Published
2022-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JZFTube, Ear Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840199507177Direct MarkingGS10
10840199507174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199507177008401995071778401995071770840199507177
1084019950717410840199507174

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-805-529-0825customerservice@korosUSA.com

Regulatory Flags#

DUNS number
007928633
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840199515995Fiberoptic Dual End Cable7332-607332-602024-12-31
10840199516008Fiberoptic Light Port7332-627332-622024-12-31
10840199516015Fiberoptic Light Port7332-647332-642024-12-31
10840199531056Impactor7585-027585-022022-03-01
10840199531186Impactor7585-447585-442022-03-01
10840199528834Comfort Plus Chisel7540-067540-062025-01-31
00840199528837Comfort Plus Chisel7540-067540-062025-01-31
10840199500007Dilator Tube Set, Single Use, Sterile 7332-99D7332-99D2022-01-31
10840199507723Separator7230-107230-102024-12-31
10840199507730Separator7230-157230-152024-12-31
10840199507747Elevator7230-187230-182024-12-31
10840199507754Elevator7230-207230-202024-12-31
10840199507761Elevator7230-257230-252024-12-31
10840199507778Elevator7230-307230-302024-12-31
10840199507785Elevator7230-357230-352024-12-31
10840199507792Elevator7230-407230-402024-12-31
10840199507808Elevator7230-427230-422024-12-31
10840199507815Elevator7230-437230-432024-12-31
10840199507877Elevator7230-607230-602024-12-31
10840199507907Hook7232-057232-052024-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811000736INKAThe Trustee for KAISER FAMILY TRUSTJZF2025-11-21
08904428724017OSSEOUS Suction Tube - Fine TipEON MEDITECH PRIVATE LIMITEDJZF2024-07-05
08904428724024OSSEOUS Suction Tube - Fine TipEON MEDITECH PRIVATE LIMITEDJZF2024-07-05
08904428724031OSSEOUS Suction Tube - Fine TipEON MEDITECH PRIVATE LIMITEDJZF2024-07-05
08904428724048OSSEOUS Suction Tube - Fine TipEON MEDITECH PRIVATE LIMITEDJZF2024-07-05
08904428724055OSSEOUS Suction Tube - Fine TipEON MEDITECH PRIVATE LIMITEDJZF2024-07-05
08904428722853OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722877OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722891OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722907OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722914OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722921OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722938OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722945OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722952OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722969OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722976OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722983OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722990OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723003OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723010OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723027OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723034OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723041OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723058OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723065OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723072OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723089OSSEOUS Zoellner Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723096OSSEOUS Zoellner Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723102OSSEOUS Zoellner Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04