FDA.reportPublic FDA data

Enteral

Primary DI
05060590882931
Brand
Enteral
Company
GBUK ENTERAL LIMITED
Model
PFC-100
Catalog number
PFC-100
Device description
Enteral, Syringe Accessories, Push Fit Cap, Single Use
Published
2022-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
05060590882948PackageGS1100In Commercial Distribution
05060590882955PackageGS124In Commercial Distribution
05060590882931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060590882948050605908829485060590882948
05060590882955050605908829555060590882955
05060590882931050605908829315060590882931

GMDN Terms#

Term, Definition table
TermDefinition
ENFit-formatted protective capA small, noninvasive, closed-ended, ENFit-formatted (ISO 80369-3) attachment intended to be attached to an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device.

Regulatory Flags#

DUNS number
216643186
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true

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