FDA.reportPublic FDA data

HyHub Vial Access Device

Primary DI
00850025688291
Brand
HyHub Vial Access Device
Company
Takeda Pharmaceuticals U.S.A., Inc.
Model
5500222
Catalog number
5500222
Device description
The HyHub™ Vial Access Device with four (4) docking stations is a stand-alone, single-use, disposable, non-pyrogenic, gamma sterilizeddevice, which is intended to support the infusion of two medicinal liquids, as prescribed, in a home environment or clinical setting. HyHub isdesigned to accommodate up to four (4) dual vial units (DVU) to be docked onto the HyHub infusion tray which allows the transfer of medicinalliquids in a needleless, sequential method using standard connections for syringes, applicable pumps, and infusion sets.
Published
2025-09-23
Public version status
New
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
60850025688293PackageGS110In Commercial Distribution
00850025688291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6085002568829360850025688293
00850025688291008500256882918500256882910850025688291

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
00850025688963HyHub Duo Vial Access Device652008365200832025-09-23
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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