FLEXBUMIN
Albumin Human
Takeda Pharmaceuticals U.S.A., Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016418550 | 3016418550 | Takeda Pharmaceuticals U.S.A., Inc. | 1 | N | 2026-01-01 | 500 Kendall St. Cambridge MA US 02142 |
| 3016938816 | 3016938816 | Takeda Pharmaceuticals U.S.A., Inc. | 1 | Y | 2026-01-01 | 95 Hayden Avenue Lexington MA US 02421 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 341972 | 1188138963 | K243404 | HyHub™ and HyHub™ Duo Vial Access Devices | LHI | 2025-07-18 |
| 285697 | 1027354768 | K121092 | FLOWEASE [SUBCUTANEOUS] INFUSION SET | FPA | 2012-06-29 |
| 285697 | 1522462555 | K092318 | BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE | LHI | 2009-10-30 |
| 285697 | 1829767631 | K042410 | BAXJECT II | LHI | 2004-10-08 |
| 285697 | 1944061258 | K031861 | MIX2VIAL TRANSFER DEVICE | LHI | 2003-07-29 |
| 341972 | 1857302180 | BK170028 | |||
| 285697 | 1158395013 | ||||
| 285697 | 1493765482 |
Product Codes Associated With Registrations#
NDC#
Flexbumin
Albumin Human
HYQVIA
Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase
HYQVIA
Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase
HYQVIA
Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase
HYQVIA
Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase
HYQVIA
Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase
GAMMAGARD
Immune Globulin Intravenous (Human)
GAMMAGARD
Immune Globulin Intravenous (Human)
GAMMAGARD Liquid
Immune Globulin Infusion (Human)
GAMMAGARD Liquid ERC
Immune Globulin Infusion (Human)
Aralast
Alpha-1-Proteinase Inhibitor (Human)
Aralast
Alpha-1-Proteinase Inhibitor (Human)
RECOMBINATE
antihemophilic factor recombinant
RECOMBINATE
antihemophilic factor recombinant
RECOMBINATE
antihemophilic factor recombinant
RECOMBINATE
antihemophilic factor recombinant
RECOMBINATE
antihemophilic factor recombinant
CUVITRU
Immune Globulin Subcutaneous (Human)
GLASSIA
ALPHA.1-PROTEINASE INHIBITOR HUMAN
RIXUBIS
COAGULATION FACTOR IX (RECOMBINANT)
RIXUBIS
COAGULATION FACTOR IX (RECOMBINANT)
RIXUBIS
COAGULATION FACTOR IX (RECOMBINANT)
RIXUBIS
COAGULATION FACTOR IX (RECOMBINANT)
RIXUBIS
COAGULATION FACTOR IX (RECOMBINANT)
ADVATE
Antihemophilic Factor (Recombinant)
ADVATE
Antihemophilic Factor (Recombinant)
ADVATE
Antihemophilic Factor (Recombinant)
ADVATE
Antihemophilic Factor (Recombinant)
ADVATE
Antihemophilic Factor (Recombinant)
ADVATE
Antihemophilic Factor (Recombinant)
ADVATE
Antihemophilic Factor (Recombinant)
HEMOFIL M
antihemophilic factor human
HEMOFIL M
antihemophilic factor human
HEMOFIL M
antihemophilic factor human
HEMOFIL M
antihemophilic factor human
CEPROTIN
Protein C Concentrate Human
CEPROTIN
Protein C Concentrate Human
ADYNOVATE
Antihemophilic Factor (Recombinant) PEGylated
ADYNOVATE
Antihemophilic Factor (Recombinant) PEGylated
PMN#
HyHub? and HyHub? Duo Vial Access Devices
Takeda Pharmaceuticals
GUDID#
HyHub Duo Vial Access Device - 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.
2025-09-23
HyHub Vial Access Device - 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.
2025-09-23
Recombinant Factor VIII Substrate, Porcine Sequence - 6521753
2025-08-01
myPKFiT for Patients Mobile Application - Mobile application used by patients for disease management
2025-01-03
myPKFiT for Healthcare Professionals - Web application used by Healthcare Professionals to generate dose calculations
2025-01-03
BAXJECT II Hi-Flow - Needleless Transfer Device
2024-06-12
BAXJECT II - Needleless Transfer Device
2024-02-29
Anti-Drug Antibody Biomarker Specimen Collection Kit - The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is to aid healthcare providers (HCPs) in collectingspecimens from patients receiving ELAPRASE® or VPRIV® commercial therapy for the treatment of Hunter syndrome and Gaucher disease
2023-10-30