Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016938816

FEI Number

3016938816

Entity Name

Takeda Pharmaceuticals U.S.A., Inc.

City/State/Country

Lexington, MA, US

Establishment Address

95 Hayden Avenue, Lexington, MA 02421, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Takeda Pharmaceuticals U.S.A., Inc. (Owner Number: 10079762)

Owner / Operator Contact Address

500 Kendall St., Cambridge, MA 02142, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Baxject II Hi-Flow Needleless Transfer Device Baxject II Needleless Transfer Device FlowEase Subcutaneous Infusion Set Obizur Recombinant Factor VIII Substrate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2020-12-22
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2020-12-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-12-22
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2025-07-03

Official Correspondent

Shilpa Gampa

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Takeda Pharmaceuticals U.S.A., Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016418550	Takeda Pharmaceuticals U.S.A., Inc.	Cambridge, MA, US
3002806503	Baxalta Belgium Manufacturing SA	Lessines Hainaut, BE
3015054258	SHIRE HUMAN GENETIC THERAPIES, INC.	Thousand Oaks, CA, US
9616848	Takeda Manufacturing Austria AG	VIENNA Wien, AT
3009340644	SHIRE HUMAN GENETIC THERAPIES, INC.	Lexington, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

Similar Registrations

Registration Number	Establishment Name	Location
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
2523676	B. BRAUN US DEVICE MANUFACTURING LLC	ALLENTOWN, PA, US
3016418550	Takeda Pharmaceuticals U.S.A., Inc.	Cambridge, MA, US
3042177665	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3012798826	BD SWITZERLAND SARL	Eysins Vaud, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016938816. Last updated year: 2026. Please use registration number 3016938816 when referencing this establishment in official correspondence.