Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000150646

FEI Number

3004393730

Entity Name

Wyeth Pharmaceuticals LLC

City/State/Country

Collegeville, PA, US

Establishment Address

500 Arcola Road, Collegeville, PA 19426, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

PFIZER INC. (Owner Number: 9924008)

Owner / Operator Contact Address

275 N Field Drive, Lake Forest, IL 60045, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ADD-Vantage ADDaptor GEL-FLOW NT Gel-Flow Kit 6mL CARPUJECT HOLDER

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	2020-01-13
LMF	Agent, Absorbable Hemostatic, Collagen Based	General, Plastic Surgery	Class 3	878.4490	2008-12-02
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2020-01-13

Official Correspondent

Kathleen Lins

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PFIZER 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
3004945409	Pfizer Inc	Parsippany, NJ, US
3004627792	Pfizer Manufacturing Belgium NV	Puurs-Sint-Amands Antwerpen, BE
3002522469	Pfizer Service Company BV	Zaventem Vlaams Brabant, BE
1925262	HOSPIRA, INC.	MCPHERSON, KS, US
1810189	PHARMACIA & UPJOHN COMPANY LLC	KALAMAZOO, MI, 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 1000150646. Last updated year: 2026. Please use registration number 1000150646 when referencing this establishment in official correspondence.