BD

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3010392988	3010392988	BD	1	N	2020-04-25	5859 Farinon Dr Ste 200 San Antonio TX US 78249

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
161218	1367663964	P970018	BD PREPSTAIN SYSTEM	MKQ	1999-06-17
161218	1217095890	P950009	AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM	MNM	1995-09-29
161218	1452734320	K993577	CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC	JTN	1999-12-01
161218	1112460131	K993186	SYNERCID, 15 UG, BBL SENSI-DISC	JTN	1999-11-03
161218	2068919674	K992734	BECTON DICKINSON SYRINGE	MEG	1999-10-01
161218	1198509898	K991702	MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578	JKA	1999-07-28
161218	1370452414	K991120	VACUTAINER BRAND CTAD TUBE (MULTIPLE)	JKA	1999-05-19
161218	1900700945	K991088	VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE	JKA	1999-05-28
161218	1996452932	K984631	BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY	LSL	1999-11-04
161218	1355561016	K982541	VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608	FMI	1998-10-28
161218	1802923469	K981517	CEFDINIR, 5 UG, SENSI-DISC	JTN	1998-06-09
161218	2028140746	K981342	ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY	GKZ	1998-06-29
161218	1934270842	K981013	VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE	JKA	1998-06-17
161218	1459435978	K980987	BECTON DICKINSON SYRINGE	FMF	1998-06-11
161218	1106511780	K980858	MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION	GKZ	1998-05-22
161218	1581219889	K980638	ADI SYPHILIS RPR LIQUID CONTROLS	GMP	1998-07-06
161218	1121598424	K980580	BECTON DICKINSON SYRINGES	FMF	1998-06-25
161218	1845319453	K980414	VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET	JKA	1998-03-03
161218	1404882371	K980098	VACUTAINER BRAND PRONTO NEEDLES HOLDER	JKA	1998-02-05
161218	1427897436	K974883	BACTEC MGIT 960 SYSTEM	MDB	1998-05-01
161218	2035939117	K974363	BECTON DICKINSON BLUNT PLASTIC CANNULA	FMI	1998-06-03
161218	1429392381	K974083	CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS	FMG	1998-01-13
161218	1713792899	K974006	BECTON DICKINSON TWINPAK	FMI	1998-01-22
161218	1359494826	K973483	FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET	GKZ	1998-02-17
161218	1773621586	K972448	COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL	JSL	1997-08-20
161218	1747760278	K972098	FOSFOMYCIN, 200 MG, SENSI-DISC	JTN	1997-07-28
161218	1589395474	K972075	VACUTAINER BRAND PPT PLASMA PREPARATION TUBE	PJE	1998-02-24
161218	1153190055	K971449	VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)	GIM	1997-06-17
161218	1998688778	K971205	TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES	GKZ	1997-12-01
161218	1064288628	K971110	TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES	GKZ	1997-11-25
161218	1384647625	K970836	TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS	GKZ	1997-08-26
161218	1806840734	K970742	TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES	GKZ	1997-10-22
161218	2054439127	K970385	SPARFLOZACIN, 5 MCG, SENSI-DISC	JTN	1997-03-10
161218	1130378748	K970326	TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES	GKZ	1997-11-21
161218	1911457767	K970212	LEVOFLOXACIN, 5MCG, SENSI-DISC	JTN	1997-03-06
161218	1428533714	K963963	MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS	GKZ	1996-12-12
161218	2014342842	K963845	MEROPENEM, 10 MCG, SENSI-DISC	JTN	1996-10-25
161218	1534815938	K963036	MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD	JTZ	1996-10-07
161218	1544581434	K961188	CEFEPIME, 30 MCG, SENSI-DISC	JTN	1996-04-05
161218	1311258911	K960313	MUELLER HINTON AGAR WITH 2% NACI	JTZ	1996-03-25
161218	2010311444	K960250	VACUTAINER BRAND PLUS SERUM & SST TUBES	JKA	1996-03-29
161218	1351527679	K954932	BBL MGIT PRODUCTS	MDB	1996-08-21
161218	1020253967	K954592	VACUTAINER BRAND PST PLASMA SEPARATION TUBE	JKA	1995-11-28
161218	1186297726	K953994	SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM	JKA	1995-09-26
161218	1811181526	K953790	BD PERISAFE EPIDURAL ANESTHESIA TRAY	CAZ	1995-11-30
161218	1750196610	K953302	FACS LOADER SYSTEM	GKZ	1995-11-20
161218	1500606851	K952861	ANGIOCATH & INSYTE AUTOGUARD CATHETERS	FOZ	1995-07-31
161218	1366199563	K952791	DIRECTIGEN MENINGITIS COMBO TEST	GTJ	1996-05-30
161218	1768996083	K951539	ENTEROCOCCUS SCREENING MEDIUM	JWY	1995-06-13
161218	1410905779	K951254	SAFETYGLIDE NEEDLE	FMI	1995-10-07
161218	1883680211	K950303	DESERET(R) I.V. LOOP AND DESERET (R) J LOOP	FPA	1995-03-14
161218	1423731790	K950057	TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP	GKZ	1995-08-22
161218	1594800913	K946288	COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM	JSM	1995-03-10
161218	1457934688	K946283	COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM	JSM	1995-03-10
161218	2012398865	K946055	TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP	GKZ	1996-02-20
161218	1588694454	K945952	VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE	JKA	1995-01-18
161218	1622741270	K945569	GCII AGAR WITH ISOVITALX(R) ENRICHMENT	JSO	1995-02-02
161218	1326736560	K944757	PISTON SYRINGES	FMI	1995-01-11
161218	1548978851	K944566	VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE	JKA	1994-11-10
161218	1753265910	K944528	BBLCRYSTAL ANAEROBE ID SYSTEM	JSP	1995-03-07
161218	1121228795	K943407	GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS	JTN	1994-10-27
161218	1925441403	K943141	B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS	FMI	1994-11-07
161218	1213791108	K943140	B-D GURADIAN CHEMOTHERAPY SHARPS COLLECTORS	FMI	1994-11-07
161218	2037895782	K943139	B-D GUARDIAN ONE PIECE SHARPS COLLECTORS	FMI	1994-11-28
161218	1401400552	K943138	VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER	MMK	1994-11-28
161218	1103401837	K943134	B-D GUARDIAN NESTABLE SHARPS COLLECTORS	FMI	1994-11-07
161218	1305998968	K941562	1ML LUER-LOK SYRINGE	FMF	1994-05-26
161218	1026307884	K940697	BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK	FPA	1994-08-30
161218	1455147678	K940359	PIPERACILLIN/TOZOBACTAM, 100/10 MCG SENSI-DISC	JTN	1994-03-01
161218	1550916376	K933486	FASCOUNT SYSTME	GKZ	1994-09-09
161218	1455706360	K933467	PRN ADAPTER	FOZ	1994-12-12
161218	1344467194	K932249	DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIA	CAZ	1993-08-27
161218	1971201489	K931374	AFFIRM VPIII MICROBIAL IDENTIFICATION TEST	MLA	1993-06-15
161218	1083075321	K931368	MICROTAINER BRAND TUBE WITH EDTA	JKA	1993-09-28
161218	1224154896	K925902	B-D LOSS OF RESISTANCE SYRINGE	CAZ	1993-01-14
161218	1719626455	K924797	CEFPODOXIME 10 MCG, SENSI DISC	JTN	1992-11-02
161218	1492615083	K924587	SIMULTEST CD3/ANTI-HLA-DR	GKZ	1993-08-05
161218	1509842408	K924439	BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA	FMI	1993-02-12
161218	1954536149	K924072	BECTON DICKINSON SAFETY-LOK SYRINGE	FMF	1992-12-17
161218	1340871564	K923952	ENOXACIN 10 MCG. SENSI SISC	JTN	1992-09-18
161218	1867469915	K923790	FACSORT FLOW CYTOMETER	GKZ	1993-09-01
161218	2006535700	K923268	AFFIRM PROCESSOR	JQW	1992-07-30
161218	1682771062	K921806	VACUTAINER(R) BRAND SST(R) AND CAT TUBES	JKA	1992-04-29
161218	1765050226	K921520	VACUTAINER BRAND LUER ADAPTER	JKA	1992-07-10
161218	1098465204	K921420	AZITHROMYCIN, 15 MCG, SENSI DISC	JTN	1992-05-08
161218	1639210925	K921193	LOMEFLOXACIN, 10 MCG, SENSI DISC	JTN	1992-04-27
161218	2021631449	K920536	AFFIRM VP SAMPLE COLLECTION SET	LIO	1992-07-30
161218	1033691029	K920473	CEFPROZIL 30MCG, SENSI DISC	JTN	1992-03-23
161218	1007679150	K920422	B-D INTERLINK SYRINGE CANNULA	FMF	1992-04-29
161218	1001118975	K920274	DIRECTIGEN NEISSERIA MENINGITIDIS TEST	GTI	1992-03-18
161218	1882407078	K920131	CLARITHROMYCIN 15MCG SENSI DISC	JTN	1992-02-06
161218	1205520060	K915480	B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.	DWD	1992-01-07
161218	1967909349	K913192	SIMULTEST(TM) IMK-LYMPHOCYTE	GKZ	1992-02-06
161218	1167351692	K911731	LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR	JCF	1992-12-15
161218	1807423128	K910506	OFLOXACIN, 5 MCG SENSI-DISC	JTN	1991-03-04
161218	1722322524	K904390	ANTI-HUMAN LEU-2A (CD8) PE	GKZ	1990-12-17
161218	1958890038	K903425	HAEMOPHILUS TEST MEDIUM (HTM) BROTH	JSO	1990-08-22
161218	1168915062	K901449	VACUTAINER PLUS WITH HEMOGARD CLOSURE	JKA	1990-08-09
161218	1070672126	K901360	LEVEEN PERITINEO-VENOUS SHUNT	KPM	1990-08-21
161218	1476606197	K900802	ANTI-HUMAN LEU-3A (CD4) FITC	GKZ	1990-05-15
161218	1625036503	K900078	SIMULTEST IMK PLUS(TM)	GKZ	1990-04-02
161218	1422358531	K895679	CEFMATZOLE 30 MCG SENSI DISC	JTN	1990-01-02
161218	1985373283	K894216	HAEMOPHILUS TEST MEDIUM (HTM)AGAR	JSO	1989-12-13
161218	1023994374	K893754	CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS	JTN	1989-07-14
161218	1056411387	K891772	SPECTINOMYCIN 100 MCG SENSI-DISC	JTN	1989-08-21
161218	1884658088	K891719	TRU-TOUCH VINYL, NON-STERILE	LYZ	1989-12-05
161218	1700710880	K891407	LEUCOPREP CELL SEPARATION TUBE	JCF	1989-05-26
161218	1368570363	K884623	SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE	GIO	1988-12-01
161218	1835139217	K881697	BREAST LESION LOCALIZATION NEEDLE	IZH	1988-09-14
161218	1081494001	K880988	PUDENDAL/LOCAL ANESTESIA BLOCK TRAY	KNE	1988-06-01
161218	1888959742	K880970	AXILLARY BLOCK NEEDLE	CAZ	1988-04-21
161218	1686548868	K880636	RETICCOUNT SOFTWARE	GKL	1988-03-21
161218	1388738792	K874425	CIPROFLOXACIN 5 MCG SENSI-DISC	JTN	1987-11-20
161218	1021816213	K872783	AMPICILLIN/SULBACTAM 20 MCG SENSI-DISC	JTN	1987-07-27
161218	1603227089	K872233	INJECT-EASE	KZH	1987-09-04
161218	1450633012	K872166	FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT	GKL	1987-09-30
161218	1783008112	K871105	THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE	LIC	1987-05-13
161218	1960729449	K870155	DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST	GTZ	1987-03-10
161218	1608374299	K865034	AZTREONAM 30 MCG. SENSI-DISC	JTN	1987-02-13
161218	1626927089	K864893	ANTI-CYTOKERATIN MONOCLONAL ANTIBODY	LYE	1988-07-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LON	108	2009-01-29
JTN	58	2011-10-18
GKZ	26	2009-07-31
JKA	25	2010-06-29
FMI	20	2016-05-27
PSZ	15	2018-03-20
FOZ	11	2020-01-24
FMF	8	2015-09-02
LSL	7	2009-11-13
FPA	5	2003-11-18
CAZ	5	2001-09-06
GQG	4	2013-11-15
MDB	4	2013-05-13
JSO	4	2010-08-20
JSM	4	2004-12-07
JTZ	4	1996-10-07
NGT	3	2017-02-02
GTY	3	2013-02-06
MKZ	3	2009-11-13
MJA	3	2002-07-13
JTY	3	1987-02-03
OYE	2	2017-07-03
PER	2	2013-08-02
ONB	2	2013-02-27
NJR	2	2012-02-16
LHI	2	2009-12-07
SCL	2	2003-09-09
JQW	2	2003-06-24
MEG	2	2001-06-13
GTJ	2	1996-05-30
JCF	2	1992-12-15
GKL	2	1988-03-21
JTW	2	1984-09-27
PMG	1	2015-12-17
OZN	1	2013-04-02
LKB	1	2013-03-20
NQX	1	2012-07-05
KNT	1	2011-09-29
OQO	1	2011-03-18
NZW	1	2009-06-10

PMN#

BD Surgiphor? 1000 mL Antimicrobial Irrigation System (910120)
2026-02-20
Bd
Denali? Vena Cava Filter System ? Femoral and Jugular/Subclavian Delivery Kit
2024-02-29
Bd
BD Veritor? System for Rapid Detection of Flu A+B CLIA Waived Kit
2023-12-05
Bd
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
2023-01-27
Bd
BD Surgiphor™ Antimicrobial Irrigation System
2022-10-14
BD
BD Veritor System For Rapid Detection Of Flu A + B CLIA Waived Kit
2018-03-20
BD
BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS
2003-03-26
BD
BD INTEGRA SYRINGE
2003-02-07
BD
BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET
2002-07-19
BD
BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757
2002-03-20
BD
BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE
2002-01-23
BD
MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT
2001-09-06
BD
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
2001-07-17
BD
INTERLINK THREADED LOCK CANNULA
2001-06-19
BD
BD SPRING BASED SYRINGE
2001-06-13
BD