FDA.reportPublic FDA data

HyHub Duo Vial Access Device

Primary DI
00850025688963
Brand
HyHub Duo Vial Access Device
Company
Takeda Pharmaceuticals U.S.A., Inc.
Model
6520083
Catalog number
6520083
Device description
The HyHub™ Duo Vial Access Device with two (2) docking stations is a stand-alone, single-use, disposable, non-pyrogenic, gamma sterilized device, which is intended to support the infusion of two medicinal liquids, as prescribed, in a home environment or clinical setting. HyHub Duo is designed to accommodate up to two (2) dual vial units (DVU) to be docked onto the HyHub Duo infusion tray which allows the transfer of medicinal liquids in a needleless, sequential method using standard connections for syringes, applicable pumps, and infusion sets.
Published
2025-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K243404000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243404000HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals2025-07-18LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60850025688965PackageGS110In Commercial Distribution
00850025688963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6085002568896560850025688965
00850025688963008500256889638500256889630850025688963

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041877817
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850025688291HyHub Vial Access Device550022255002222025-09-23
00198815000107Recombinant Factor VIII Substrate, Porcine Sequence652175365217532025-08-01
00850025688819myPKFiT for Healthcare ProfessionalsV32025-01-03
00850025688826myPKFiT for Patients Mobile ApplicationV22025-01-03
00850025688871BAXJECT II Hi-Flow34007692024-06-12
00850025688864BAXJECT II650781665078162024-02-29
00850025688888Anti-Drug Antibody Biomarker Specimen Collection Kit500083350008332023-10-30

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