FDA.reportPublic FDA data

Enteral

Primary DI
05060498307611
Brand
Enteral
Company
GBUK ENTERAL LIMITED
Model
FNISO-50
Catalog number
FNISO-50
Device description
Enteral, Drawing Up Device, Filter Needle, Single Use 5µm 18G x 50mm
Published
2022-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KYXDISPENSER, LIQUID MEDICATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060498307604PackageGS130In Commercial Distribution
05060498307611PackageGS116In Commercial Distribution
05060498307598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060498307604050604983076045060498307604
05060498307611050604983076115060498307611
05060498307598050604983075985060498307598

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer needle, filteringA slender, rigid, sharp or blunt tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It includes an integral filter (e.g., a microporous stainless steel filter) intended to retain micro-particles from the drug as it flows through the needle to reduce the risk of particle contamination of the patient medication; it does not include a back-pressure venting feature. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
216643186
Device count
1
DM exempt
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060999351564EnteralESCF.075-ISOSAF-USESCF.075-ISOSAF-US2025-08-20
05060999351595EnteralESCF.150-ISOSAF-USESCF.150-ISOSAF-US2025-08-20
05060999351625EnteralBESCF.075-ISOSAF-USBESCF.075-ISOSAF-US2025-08-20
05060999351656EnteralBESCF.143-ISOSAF-USBESCF.143-ISOSAF-US2025-08-20
05060999351571EnteralESCF.075-ISOSAF-USESCF.075-ISOSAF-US2025-08-20
05060999351601EnteralESCF.150-ISOSAF-USESCF.150-ISOSAF-US2025-08-20
05060999351632EnteralBESCF.075-ISOSAF-USBESCF.075-ISOSAF-US2025-08-20
05060999351670EnteralBESCF.143-ISOSAF-USBESCF.143-ISOSAF-US2025-08-20
05060590880746EnteralPHX0-6PHX0-62022-11-01
05060590883754EnteralEISO-35EISO-352022-10-28
05060460844083EnteralESCF.075-ISOSAFESCF.075-ISOSAF2022-10-28
05060460844113EnteralESCF.150-ISOSAFESCF.150-ISOSAF2022-10-28
05060999350017NutricareYNC06.050ISOSAF-ROWYNC06.050-US2024-10-29
05060999350048NutricareYNC06.080ISOSAF-ROWYNC06.080-US2024-10-29
05060999350079NutricareYNC06.110ISOSAF-ROWYNC06.110-US2024-10-29
05060999350109NutricareYNC08.050ISOSAF-ROWYNC08.050-US2024-10-29
05060999350130NutricareYNC08.080ISOSAF-ROWYNC08.080-US2024-10-29
05060999350161NutricareYNC08.092ISOSAF-ROWYNC08.092-US2024-10-29
05060999350192NutricareYNC08.110ISOSAF-ROWYNC08.110-US2024-10-29
05060999350222NutricareYNC08.120ISOSAF-ROWYNC08.120-US2024-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18859299184705SMARTeZ Fluid Transfer SetEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKYX2026-04-08
08809692500285Dr.INVIVOROKIT HEALTHCARE Inc.KYX2026-04-02
00008279897857Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
30827989000354Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-09-16
10827989003924Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003931Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003948Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003955Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989000381Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989000404Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989003429Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989003801Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-20
10827989000398Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-03
10827989004167Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-03
10827989000336Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989000343Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989000350Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989000770Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989004044Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989004051Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989004068Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-29
10827989001098Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001128Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001159Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001180Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001210Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001241Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001272Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001302Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16
10827989001333Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-04-16