Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616657

FEI Number

3005698992

Entity Name

BECTON, DICKINSON AND CO.

City/State/Country

DROGHEDA Louth, IE

Establishment Address

DONORE RD., DROGHEDA Louth --, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Becton Dickinson and Company (Owner Number: 9922032)

Owner / Operator Contact Address

One Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153481

PMA Number

N/A

All Registered Proprietary Names

Posiflush SF

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2016-08-01

Official Correspondent

No official correspondent registered.

US Agent Details

John Roberts Email: john_w_roberts@bd.com Phone: (201) 8474760

Related Public Records

Same Entity

Becton Dickinson and Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9680577	BECTON DICKINSON GMBH	HEIDELBERG Baden-Wurttemberg, DE
3003916417	BECTON DICKINSON IND. CIRURGICAS LTDA.	CURITIBA Parana, BR
3036495171	BD Biosciences San Diego	San Diego, CA, US
3015292643	BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES	San Diego, CA, US
3010141591	BD Kiestra B.V.	Drachten Fryslan, NL

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0035-2011	Excelsior Medical Corp	2	Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use
Z-0044-2007	Excelsior Medical Corp	2	0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.

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3014421917	O&M Halyard, Inc.	Alpharetta, GA, US
3016413378	JIAXING TIANHE PHARMACEUTICAL CO., LTD.	Jiaxing Zhejiang, CN
3005934752	MEDXL INC	Pointe-Claire Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616657. Last updated year: 2026. Please use registration number 9616657 when referencing this establishment in official correspondence.