CAREFUSION 2200, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1423507	3008002452	CAREFUSION 2200, INC.	1	Y	2026-01-01	75 North Fairway Drive Vernon Hills IL US 60061
1625685	1625685	CAREFUSION 2200, INC.	1	N	2026-01-01	400 East Foster Rd Mannford OK US 74044
1526531	1526531	CAREFUSION 2200, INC.	1	N	2020-04-25	17820 ENGLEWOOD DR. CLEVELAND OH US 44130
1923569	1923569	CAREFUSION 2200, INC.	1	N	2020-04-25	5 SUNNEN DR. Saint Louis MO US 63143

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
110332	1717453925	K993147	DECAP	FPA	1999-11-02
110332	1229629472	K992734	BECTON DICKINSON SYRINGE	MEG	1999-10-01
110332	1665931909	K991928	MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS	GCJ	1999-06-25
109715	1665931909	K991928	MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS	GCJ	1999-06-25
109715	1710423202	K991589	FLEXIBLE VASCULAR CLAMP, VERSION 2	DXC	1999-05-18
110332	1710423202	K991589	FLEXIBLE VASCULAR CLAMP, VERSION 2	DXC	1999-05-18
110332	1149693364	K983299	ALLEGIANCE GENESIS CONTAINER SYSTEM	FRG	2000-08-04
108965	1625772099	K982269	CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA	MIA	1998-07-23
110332	1625772099	K982269	CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA	MIA	1998-07-23
110332	1410354471	K980987	BECTON DICKINSON SYRINGE	FMF	1998-06-11
110332	1499339478	K980580	BECTON DICKINSON SYRINGES	FMF	1998-06-25
110332	2031637084	K974769	COSGROVE CLAMP	DXC	1998-06-12
109715	2031637084	K974769	COSGROVE CLAMP	DXC	1998-06-12
110332	1516635326	K974363	BECTON DICKINSON BLUNT PLASTIC CANNULA	FMI	1998-06-03
110332	1067986992	K974083	CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS	FMG	1998-01-13
110332	1841521785	K974006	BECTON DICKINSON TWINPAK	FMI	1998-01-22
108965	1088879287	K973129	DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS	KPM	1998-03-17
110332	1088879287	K973129	DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS	KPM	1998-03-17
108965	1913001156	K971753	DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500	DWM	1997-06-27
110332	1913001156	K971753	DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500	DWM	1997-06-27
110332	1289878062	K970485	SMARTSITE ACCESS PIN	FPA	1997-04-21
109715	1753651281	K964402	VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM	GZT	1997-01-23
110332	1753651281	K964402	VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM	GZT	1997-01-23
108965	1469389159	K963390	BIOPSY INTRODUCER NEEDLE	KNW	1996-10-10
110332	1469389159	K963390	BIOPSY INTRODUCER NEEDLE	KNW	1996-10-10
108965	1109410890	K962907	SKINNY,FRANSEEN,WESCOTT NEEDLES	KNW	1996-10-23
110332	1109410890	K962907	SKINNY,FRANSEEN,WESCOTT NEEDLES	KNW	1996-10-23
110332	1916948442	K960509	18 GAUGE TRU-CUT BIOPSY NEEDLE	KNW	1996-04-04
110332	1708699106	K960280	IVAC NEEDLE FREE VALVE ADMINISTRATION SETS	FPA	1996-04-04
110332	1561372225	K960064	TEMNO ACHIEVE BIOPSY NEEDLE	KNW	1996-04-05
110332	1438046222	K953790	BD PERISAFE EPIDURAL ANESTHESIA TRAY	CAZ	1995-11-30
110332	1437107986	K951922	ADMINISTRATION SETS WITH BALL FLOAT	FPA	1995-07-19
108965	1199517673	K951524	THORACENTESIS CATHETER	JOL	1995-07-06
110332	1199517673	K951524	THORACENTESIS CATHETER	JOL	1995-07-06
110332	1606277608	K951413	FOGARTY-HYDRAGRIP SURGICAL CLAMPS	DXC	1995-08-18
109715	1606277608	K951413	FOGARTY-HYDRAGRIP SURGICAL CLAMPS	DXC	1995-08-18
110332	2000273325	K951254	SAFETYGLIDE NEEDLE	FMI	1995-10-07
110332	1359512914	K945070	VERSASAE PLASTIC CANNULA- 11 GAUGE	FPA	1995-01-13
110332	1511739861	K944757	PISTON SYRINGES	FMI	1995-01-11
110332	1437130637	K944320	VENTED/NON-VENTED GEMINI ADMINISTRATION SET	FPA	1995-02-14
108965	1426666428	K943968	TUNNELER	MDM	1995-03-01
110332	1426666428	K943968	TUNNELER	MDM	1995-03-01
110332	1474808604	K943941	SAFESTART VASCULAR ACCESS START KIT	LRS	1994-10-20
110332	1093697292	K943141	B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS	FMI	1994-11-07
110332	1491331416	K943140	B-D GURADIAN CHEMOTHERAPY SHARPS COLLECTORS	FMI	1994-11-07
110332	1746528178	K943139	B-D GUARDIAN ONE PIECE SHARPS COLLECTORS	FMI	1994-11-28
110332	1410021953	K943138	VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER	MMK	1994-11-28
110332	1447557217	K943134	B-D GUARDIAN NESTABLE SHARPS COLLECTORS	FMI	1994-11-07
110332	1548418491	K942045	INSYTE INTRODUCER CATHETER	FOZ	1995-01-09
110332	1889598794	K941562	1ML LUER-LOK SYRINGE	FMF	1994-05-26
110332	2000454419	K940697	BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK	FPA	1994-08-30
110332	1035260627	K932249	DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIA	CAZ	1993-08-27
110332	1965387739	K931340	GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR	GCS	1993-07-01
109715	1965387739	K931340	GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR	GCS	1993-07-01
110332	1204979062	K930667	REUSABLE LAPAROSCOPIC INSTRUMENTS	GCJ	1994-05-16
109715	1204979062	K930667	REUSABLE LAPAROSCOPIC INSTRUMENTS	GCJ	1994-05-16
110332	1391707528	K930666	REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERY	GEI	1994-05-19
109715	1391707528	K930666	REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERY	GEI	1994-05-19
108965	1528109219	K930217	BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE	FMI	1994-02-28
110332	1528109219	K930217	BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE	FMI	1994-02-28
110332	1628493548	K926559	PROACT BIOPSY NEEDLE ENCHANCEMENTS	FCG	1993-03-22
110332	1874864256	K925902	B-D LOSS OF RESISTANCE SYRINGE	CAZ	1993-01-14
110332	1098969270	K924718	SHROUDED NEEDLE DEVICES	FPA	1993-06-18
110332	1936696270	K924439	BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA	FMI	1993-02-12
110332	1184867044	K924072	BECTON DICKINSON SAFETY-LOK SYRINGE	FMF	1992-12-17
110332	1643259188	K920422	B-D INTERLINK SYRINGE CANNULA	FMF	1992-04-29
110332	1098086596	K915480	B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.	DWD	1992-01-07
110332	2018570588	K913306	BONE-TEMNO/STERNUM-TEMNO	LWE	1991-11-01
108965	1180915901	K910693	PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET	JOL	1991-10-17
110332	1180915901	K910693	PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET	JOL	1991-10-17
110332	2056909388	K904173	INSULATED ELECTRODES AND LAPAROSCOPIC PROBICS	HET	1990-12-10
109715	2056909388	K904173	INSULATED ELECTRODES AND LAPAROSCOPIC PROBICS	HET	1990-12-10
110332	1545605118	K904142	GRASPING FORCEPS/ALIGATOR FORCEPS/NEEDLE HOLDERS	HET	1990-12-05
110332	1654366598	K902319	BAUER TEMNO BIOPSY NEEDLE	FCG	1990-09-06
110332	1920847090	K895395	V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR	GZT	1989-10-19
109715	1920847090	K895395	V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR	GZT	1989-10-19
108965	1900027881	K894031	PHARMASEAL GENETIC AMNIOCENTESIS TRAY	HIO	1989-08-04
110332	1900027881	K894031	PHARMASEAL GENETIC AMNIOCENTESIS TRAY	HIO	1989-08-04
108965	2008910248	K884290	BAXTER DISPOSABLE CIRCUMCISION TRAY	HFX	1988-12-08
110332	2008910248	K884290	BAXTER DISPOSABLE CIRCUMCISION TRAY	HFX	1988-12-08
110332	1832743584	K882302	IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080	FPA	1988-07-12
110332	1110145474	K881697	BREAST LESION LOCALIZATION NEEDLE	IZH	1988-09-14
110332	1899751148	K880988	PUDENDAL/LOCAL ANESTESIA BLOCK TRAY	KNE	1988-06-01
110332	2066899901	K880970	AXILLARY BLOCK NEEDLE	CAZ	1988-04-21
110332	1308759534	K874564	MINIMED III INFUSION PUMP & UNI-SET ADMIN SET	FRN	1988-02-11
110332	1224980285	K862610	ULTRA-VUE SPINAL TYPE BIOPSY NEEDLE	FMI	1987-02-04
110332	1707730665	K850505	DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER	BSO	1985-03-11
109714	1962562204	K844652	C.A.S.E. CONTAINER	FSM	1984-12-12
110332	1962562204	K844652	C.A.S.E. CONTAINER	FSM	1984-12-12
108965	1351470933	K832556	NEONATAL LUMBAR PUNCTURE TRAY	FMI	1983-09-12
110332	1351470933	K832556	NEONATAL LUMBAR PUNCTURE TRAY	FMI	1983-09-12
110332	1266173287	K820278	INTRAVASCULAR ADMINISTRATION SET	FPA	1982-02-18
110332	1203061377	K813338	BIOPSY NEEDLES & TRAYS	FSH	1982-01-28
108965	1660978562	K813336	LAZARUS-NELSON PERITONEAL LAVAGE TRAY	FKO	1981-12-18
110332	1660978562	K813336	LAZARUS-NELSON PERITONEAL LAVAGE TRAY	FKO	1981-12-18
110332	1140047922	K811885	30-30-2 700 SYRINGE EXTENSION SET	FPA	1981-08-25
110332	1301934432	K810483	FALLOPIAN TUBE FORCEPS	KNA	1981-03-11
109715	1301934432	K810483	FALLOPIAN TUBE FORCEPS	KNA	1981-03-11
110332	1851009544	K801343	B-D FILTER NEEDLE	FPB	1980-06-20
110332	1888217674	K790582	INTRAVASCULAR ADMINISTRATION SET	FPA	1979-05-29
110332	1048541398	K790108	FILTERSET 0.22, I.V. PUMP	FPA	1979-03-06
110332	1915517116	K780130	BURETTE INTRAVENOUS ADMIN. SETS.	FPA	1978-02-21
108965	1635658847	K761230	AMMOCENTESIS TRAY (KIT)	HIO	1976-12-17
110332	1635658847	K761230	AMMOCENTESIS TRAY (KIT)	HIO	1976-12-17
110332	1813762100	K253996	BD Surgiphor™ Antimicrobial Irrigation System (910110)	FQH	2026-02-25
110332	1530728980	K253445	BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)	FQH	2026-02-20
110332	1728166757	K251654	BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter	FOZ	2025-06-27
110332	1192445530	K251422	BD Saf-T-Intima™ Subcutaneous Catheter System	FOZ	2025-10-08
110332	1260255015	K251155	BD Cathena™ Safety IV Catheter	FOZ	2025-07-11
110332	1012709256	K250884	0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe	NGT	2025-12-02
110332	1132887101	K250682	BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector	FOZ	2025-06-03
110332	1174793862	K250325	BD Alaris Pump Infusion Set	FPA	2025-10-30
110332	1790331684	K250059	BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)	ONB	2025-09-12
110332	1793324438	K243403	BD Nexiva™ Closed IV Catheter System	FOZ	2025-07-25
110332	1820982000	K241946	PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50-	PNG	2024-12-06
110332	1625336213	K233529	BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector	FOZ	2023-12-01
110332	1573357520	K233021	BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device	LHI	2024-03-06
110332	1660620558	K231888	BD Texium™ Needle-Free Syringe	FMF	2023-09-25
110332	2042704273	K231239	Nexiva™ Closed IV Catheter System with NearPort™ IV Access	FOZ	2023-09-22
110332	1314505007	K230865	PIVO™ Pro Needle-free Blood Collection Device	JKA	2023-09-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FPA	35	2025-10-30
FMI	20	2016-05-27
FOZ	16	2025-10-08
DWM	14	2016-10-31
FMF	12	2023-09-25
KNW	11	2017-09-11
KCT	10	2016-03-21
GCJ	10	2016-02-01
PNG	9	2024-12-06
KPM	8	2017-11-02
GEI	8	2017-05-04
ONB	7	2025-09-12
JKA	7	2023-09-28
LHI	6	2024-03-06
CAZ	6	2022-05-19
GZT	6	2009-03-18
DXC	6	1999-05-18
NGT	4	2025-12-02
BSP	4	2022-07-01
JOL	4	1995-07-06
HIO	4	1989-08-04
FQH	3	2026-02-25
FCG	3	2003-01-15
FRG	3	2002-08-20
HET	3	1990-12-10
NZW	2	2017-02-27
HES	2	2014-04-21
NDN	2	2009-07-01
FMG	2	2007-12-14
SCL	2	2003-09-09
MEG	2	2001-06-13
HBL	2	2000-08-29
MIA	2	1998-07-23
MDM	2	1995-03-01
GCS	2	1993-07-01
HFX	2	1988-12-08
FSM	2	1984-12-12
FKO	2	1981-12-18
KNA	2	1981-03-11
QTI	1	2022-07-16

PMN#

AirLife Autofill Humidification Chamber
2016-08-25
CAREFUSION 2200, INC.
GENESIS REUSABLE RIGID CONTAINER SYSTEM
2014-08-27
CAREFUSION 2200, INC.
SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS
2012-09-07
CAREFUSION 2200, INC.
GENESIS REUSABLE RIGID CONTAINER SYSTEM
2012-04-27
CAREFUSION 2200, INC.
DIAMOND-FLEX(R) GRASPERS
2011-05-06
CAREFUSION 2200, INC.

CAREFUSION 2200, INC.

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

AirLife Autofill Humidification Chamber

GENESIS REUSABLE RIGID CONTAINER SYSTEM

SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS

GENESIS REUSABLE RIGID CONTAINER SYSTEM

DIAMOND-FLEX(R) GRASPERS