Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2618282

FEI Number

2649711

Entity Name

BD Puerto Rico LLC

City/State/Country

Juncos, PR, US

Establishment Address

RD 31, KM 24.3, Juncos, PR 00777, US

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

K230493

PMA Number

N/A

All Registered Proprietary Names

BD Microtainer Tube NaFL/Na2EDTA Breast Lesion Localization Needle Microtainer Brand Tube with EDTA Epilor LOR Syringe BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube BD INTERLINK CANNULA SYSTEMS BECTON DICKINSON INTE Pudendal/Local Anesthesia Block Bonanno Suprapubic Bladder Drainage BD Durasafe Combined Anesthesia Kit BD Microtainer® Quikheel Lancets BD Microtainer® Contact-Activated Lancets BD Quincke Spinal Needle BD Spinal Introducer Needle BD Whitacre Spinal Needle BD Perisafe Tuohy Epidural Needle BD Perisafe Weiss Epidural Needle BD Microtainer Tubes with Microgard BD Microtainer Tubes BD Microtainer® Tubes with K2E (K2EDTA) BD Epilor Syringe HEIMLICH CHEST DRAIN VALVE SUCTION COLLECTION BOTTLE BD LUER TIP CAPS BD ORAL TIP CAPS BD ORAL SYRINGES BD Arthrogram Tray BD Durasafe Plus BD Perisafe BD Spinal & Epidural Anesthesia Trays BD Durasafe BD Myelogram Trays Catheter Connector BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube Catheter Introducer Catheter Adapter BD CytoRich Clear Collection Vial BD Microtainer® Tube Extender BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2008-01-07
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2008-02-28
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2008-01-07
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2008-02-20
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2026-04-14
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2001-08-29
KNE	Set, Anesthesia, Obstetric	Obstetrics/Gynecology	Class 2	884.5100	2008-02-28
FEZ	Catheter And Tube, Suprapubic	Gastroenterology, Urology	Class 2	876.5090	2007-12-07
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2008-02-28
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2008-02-28
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-01-04
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2022-06-13
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2022-07-01
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2008-01-07
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2023-12-06
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2022-06-10
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2001-08-03
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2001-08-03
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2014-06-03
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2008-02-27
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2023-12-06
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2007-12-07
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2017-03-16
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2023-12-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K072702	Stryker Instruments, Instruments Div.	STRYKER ANTIMIC CATHETER	2008-03-19

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-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0019-2023	Hobbs Medical, Inc.	1	Hobbs Scope Introducer Catalog Number: 4650
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2618282. Last updated year: 2026. Please use registration number 2618282 when referencing this establishment in official correspondence.