FDA.reportPublic FDA data

SMARTeZ Fluid Transfer Set

Primary DI
78859299180112
Brand
SMARTeZ Fluid Transfer Set
Company
EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
Model
470110
Device description
SMARTeZ Fluid Transfer Set (Extension Tube 30cm)
Published
2020-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
78859299180112PackageGS150In Commercial Distribution
18859299180110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7885929918011278859299180112
1885929918011018859299180110

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of sterile devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
662213220
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18859299123612eZSURE™426030SF2026-04-10
18859299123629eZSURE™426040SF2026-04-10
18859299123636eZSURE™426110SF2026-04-10
18859299124589eZSURE™426210SF2026-04-10
18859299184705SMARTeZ Fluid Transfer Set4700102026-04-08
18859299131013ProSeal CSTD4210102026-03-11
18859299131051ProSeal CSTD4210502026-03-11
18859299133857ProSeal CSTD4238502026-03-11
38859299131017ProSeal CSTD4210102026-03-11
38859299131055ProSeal CSTD4210502026-03-11
38859299133851ProSeal CSTD4238502026-03-11
28859299198129SMARTeZ Pump KVO4981212026-02-03
28859299198136SMARTeZ Pump KVO4981312026-02-03
48859299198123SMARTeZ Pump KVO4981212026-02-03
48859299198130SMARTeZ Pump KVO4981312026-02-03
28859299198143SMARTeZ Pump KVO4981412026-02-03
68859299100045SMARTeZ Pump4800462025-11-14
18859299101177SMARTeZ Pump4811712025-11-14
78859299100042SMARTeZ Pump4800462025-11-14
18859299119950ProSeal CSTD423370ST2025-09-11

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