HyHub Vial Access Device 5500222

GUDID 00850025688291

The HyHub™ Vial Access Device with four (4) 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 is designed to accommodate up to four (4) dual vial units (DVU) to be docked onto the HyHub infusion tray which allows the transfer of medicinal liquids in a needleless, sequential method using standard connections for syringes, applicable pumps, and infusion sets.

Takeda Pharmaceuticals U.S.A., Inc.

Fluid transfer set, general-purpose

• Primary Device ID: 00850025688291
• NIH Device Record Key: 21623c40-cd81-44e0-9ddc-1406dfa5d3ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HyHub Vial Access Device
• Version Model Number: 5500222
• Catalog Number: 5500222
• Company DUNS: 041877817
• Company Name: Takeda Pharmaceuticals U.S.A., Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850025688291 [Primary]
GS1	60850025688293 [Package]; Package: Shipper Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243404

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-01
• Device Publish Date: 2025-09-23

Devices Manufactured by Takeda Pharmaceuticals U.S.A., Inc.

• 00850025688291 - HyHub Vial Access Device: 2025-10-01The HyHub™ Vial Access Device with four (4) 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 is designed to accommodate up to four (4) dual vial units (DVU) to be docked onto the HyHub infusion tray which allows the transfer of medicinal liquids in a needleless, sequential method using standard connections for syringes, applicable pumps, and infusion sets.
• 00850025688291 - HyHub Vial Access Device: 2025-10-01 The HyHub™ Vial Access Device with four (4) docking stations is a stand-alone, single-use, disposable, non-pyrogenic, gamma st
• 00850025688963 - HyHub Duo Vial Access Device: 2025-10-01 The HyHub™ Duo Vial Access Device with two (2) docking stations is a stand-alone, single-use, disposable, non-pyrogenic, gamma
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• 00850025688888 - Anti-Drug Antibody Biomarker Specimen Collection Kit: 2023-11-07 The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is to aid healthcare providers (HCPs) in collectings