Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000223297

FEI Number

3000223297

Entity Name

West Pharma. Services IL, Ltd.

City/State/Country

Ra'anana Central, IL

Establishment Address

4 HaSheizaf St., Ra'anana Central 4366411, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

WEST PHARMACEUTICAL SERVICES, INC. (Owner Number: 2514921)

Owner / Operator Contact Address

530 Herman O. West Drive, Exton, PA 19341, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231071

PMA Number

N/A

All Registered Proprietary Names

MixJect® Transfer Device Swabable Vial Adapter Vented Vial Adapter Transfer Device Mix2Vial Transfer Device Mix2Vial® Transfer Device

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	2023-05-27
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2008-12-28
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2023-12-19
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2007-10-14
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2007-10-14
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-01-24

Official Correspondent

No official correspondent registered.

US Agent Details

Lynn Lundy Business: West Pharmaceutical Services, Inc. Email: lynn.lundy@westpharma.com Phone: (484) 8853298

Related Public Records

Same Entity

WEST PHARMACEUTICAL SERVICES, 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
3015176617	West Pharmaceutical Services AZ, Inc.	Scottsdale, AZ, US
3010893867	Tech Group Europe Limited t/a West	Mulhaddart Dublin, IE
3005042488	West Contract Manufacturing, LLC	Cidra, PR, US
2032861	West Pharmaceutical Services Arizona, Inc.	Tempe, AZ, US
2032862	West Pharmaceutical Services AZ, Inc.	SCOTTSDALE, AZ, 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
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 3000223297. Last updated year: 2026. Please use registration number 3000223297 when referencing this establishment in official correspondence.