FDA.reportPublic FDA data

Enteral

Primary DI
05060590883648
Brand
Enteral
Company
GBUK GROUP LIMITED
Model
PFCO-50NS
Catalog number
PFCO-50NS
Device description
Enteral, Syringe Accessories, Push Fit Cap, Single Use
Published
2022-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
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
05060590883921PackageGS14In Commercial Distribution
05060590883969PackageGS112In Commercial Distribution
05060590883983PackageGS110In Commercial Distribution
05060590885352PackageGS18In Commercial Distribution
05060590887790PackageGS180In Commercial Distribution
05060590883648PrimaryGS10
45060590883646Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060590883921050605908839215060590883921
05060590883969050605908839695060590883969
05060590883983050605908839835060590883983
05060590885352050605908853525060590885352
05060590887790050605908877905060590887790
05060590883648050605908836485060590883648
4506059088364645060590883646

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
220705343
Device count
50
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
10850002550006EnteralVED-691VED-6912022-11-01
10850002550013EnteralVED-692VED-6922022-11-01
10850002550020EnteralVED-693VED-6932022-11-01
10850002550037EnteralVED-694VED-6942022-11-01
10850801006995EnteralVED-690VED-6902022-11-01
00850801006967EnteralVED-670VED-6702022-10-20
05056038302895TenderTipTT02-05-E31TT02-05-E312023-06-02
05056038302925TenderTipTT02-06-E31TT02-06-E312023-06-02
05056038302956TenderTipTT02-06-P31TT02-06-P312023-06-02
05056038302987TenderTipTT02-07-P31TT02-07-P312023-06-02
05056038303014TenderTipTT02-08-E31TT02-08-E312023-06-02
05056038303045TenderTipTT02-08-P31TT02-08-P312023-06-02
05056038303083TenderTipTT02-10-E54-NTT02-10-E54-N2023-06-02
05056038303137TenderTipTT02-12-E54-NTT02-12-E54-N2023-06-02
05056038303175TenderTipTT02-12-T34-NTT02-12-T34-N2023-06-02
05056038303212TenderTipTT02-14-E54-NTT02-14-E54-N2023-06-02
05056038303250TenderTipTT02-14-T34-NTT02-14-T34-N2023-06-02
05056038303298TenderTipTT03-12-E54-NTT03-12-E54-N2023-06-02
05056038303335TenderTipTT03-12-T34-NTT03-12-T34-N2023-06-02
05056038303373TenderTipTT03-14-E54-NTT03-14-E54-N2023-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
MHC18140012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
09420060205039haakaaTHINK GREEN LIMITEDKYX2026-09-20
09420060205046haakaaTHINK GREEN LIMITEDKYX2026-09-20
10840330702765ProCureTwin Med, LLCKYX2026-07-08
00827989008175Topi-CLICKHealth Care Logistics, Inc.KYX2026-06-15
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