Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015054258

FEI Number

3015054258

Entity Name

SHIRE HUMAN GENETIC THERAPIES, INC.

City/State/Country

Thousand Oaks, CA, US

Establishment Address

1445 Lawrence Drive, Thousand Oaks, CA 91320, US

Establishment Type(s)

Repack or Relabel Medical Device

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Syringe Piston

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-06-22

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
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
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-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
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015054258. Last updated year: 2026. Please use registration number 3015054258 when referencing this establishment in official correspondence.