Takeda Pharmaceuticals U.S.A., Inc.

FDA Device Registration & Listing · Cambridge, MA, US · Registration 3016418550

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016418550
FEI Number
3016418550
Entity Name
Takeda Pharmaceuticals U.S.A., Inc.
City/State/Country
Cambridge, MA, US
Establishment Address
500 Kendall St., Cambridge, MA 02142, US
Establishment Type(s)
Manufacture Medical Device
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
N
Expiration Date (Year)
2026
510(k) Number
BK170028
PMA Number
N/A

All Registered Proprietary Names

HyHub™ and HyHub™ Duo Vial Access Devices myPKFiT

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 2025-07-23
PHY Sparse Sample Pk Profile And Dosing Software Anesthesiology Class 2 868.1890 2023-01-12

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
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
3016938816 Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA, US
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

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.

Similar Registrations

Registration Number Establishment Name Location
3043226252 ZAPALIGN LLC Fort Lauderdale, FL, US
2523676 B. BRAUN US DEVICE MANUFACTURING LLC ALLENTOWN, PA, US
3042177665 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BEST Noord-Brabant, NL
3012798826 BD SWITZERLAND SARL Eysins Vaud, CH
2032098 Isomedix Operations, Inc ONTARIO, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016418550. Last updated year: 2026. Please use registration number 3016418550 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.