Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009340644

FEI Number

3009340644

Entity Name

SHIRE HUMAN GENETIC THERAPIES, INC.

City/State/Country

Lexington, MA, US

Establishment Address

300 SHIRE WAY, 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: 10051446)

Owner / Operator Contact Address

500 Kendall St., Cambridge, MA 02142, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K070100

PMA Number

N/A

All Registered Proprietary Names

Cinryze Baxject II Hi-Flow Needleless Transfer Device Baxject II Needleless Transfer Device Natpara Q-Cliq Pen

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	2018-01-19
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2018-11-05
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2018-11-05
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-03-18

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
3016938816	Takeda Pharmaceuticals U.S.A., 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
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

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-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

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 3009340644. Last updated year: 2026. Please use registration number 3009340644 when referencing this establishment in official correspondence.