FDA.reportPublic FDA data

ADRx Admixture System

Primary DI
18859299138111
Brand
ADRx Admixture System
Company
EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
Model
428110
Device description
ADRx Single Dose for 13 mm Vial
Published
2026-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252987000ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.2026-06-12LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38859299138115PackageGS180In Commercial Distribution
18859299138111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3885929913811538859299138115
1885929913811118859299138111

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of 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 not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Regulatory Flags#

DUNS number
662213220
Device count
1
DM exempt
false
Premarket exempt
false
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18859299138128ADRx Admixture System4281202026-08-01
18859299138326ADRx Admixture System4283202026-08-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18859299138128ADRx Admixture SystemEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDLHI2026-08-01
18859299138326ADRx Admixture SystemEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDLHI2026-08-01
10813153027384CodanCodan US CorporationLHI2026-06-25
08699443581898FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443581911FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443581928FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585292FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585308FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585315FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585322FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585339FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
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08699443580174FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2024-10-07
10815879021783IV PlusNEXUS MEDICAL, LLCLHI2024-09-27
10815879021745IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
10815879021752IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
08699443580167FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2024-08-05
10815879021677 Nexus TKO®NEXUS MEDICAL, LLCLHI2024-04-02
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10815879021660IV PlusNEXUS MEDICAL, LLCLHI2024-03-05
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10815879021547IV PlusNEXUS MEDICAL, LLCLHI2022-09-08
10193489896848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LHI2022-08-04
10815879021523IV PlusNEXUS MEDICAL, LLCLHI2022-06-15
10612479261959McKessonMCKESSON MEDICAL-SURGICAL INC.LHI2022-02-24
10612479261973McKessonMCKESSON MEDICAL-SURGICAL INC.LHI2022-02-24
08426314778770GRI-FILL 6 to1 SetLABORATORIOS GRIFOLS SALHI2021-10-25
10815879021394IV PlusNEXUS MEDICAL, LLCLHI2021-02-26
10815879021295IV PlusNEXUS MEDICAL, LLCLHI2021-01-20