Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1423507

FEI Number

3008002452

Entity Name

CAREFUSION 2200, INC.

City/State/Country

Vernon Hills, IL, US

Establishment Address

75 North Fairway Drive, Vernon Hills, IL 60061, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

CAREFUSION (Owner Number: 10030506)

Owner / Operator Contact Address

75 N Fairway Dr, Vernon Hills, IL 60061, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K943134

PMA Number

N/A

All Registered Proprietary Names

BD Hypodermic Needles BD 27G and 29G Spinal Needles BD Intelliport System SmartSite Bag set, administration, intravascular BD Nexiva Closed IV Catheter System Texium Closed Male Luer set, administration, intravascular BD Reusable Stopcocks and Adaptors BD Nexiva Diffusics Closed IV Catheter System HEIMLICH CHEST DRAIN VALVE set, administration, intravascular BD Phaseal Optima spike Set (C180-O) BD PhaSeal Optima Connecting Set (C83-O) PIVO PIVO Pro Needle-free Blood Collection Device PIVO BD Syringe PhaSeal: Protector, P21, P28, P50, P14, P53, P50Multi, P21Multi, P14Multi PhaSeal: Hanger for IV Bag, M55 PleurX BD Catheter Tip Syringe MINIMED III INFUSION PUMP & UNI-SET ADMIN SET Interlink Blunt Plastic Cannula BD Alaris Infusion Set BD Whitacre Spinal Needle BD Spinal Needle BD Quincke Spinal Needle BD Eclipse Bifurcated Needle BD SafetyLok Chemotherapy Sharps Collector Ultra-Vue Needle w/ Spinal Point PleurX Surgiphor 1000mL Epilor LOR Syringe Texium BD Integra BECTON DICKINSON INTE AvaMax T-Handle Jamshidi Bone Marrow Biopsy/Aspiration Needle Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle Jamshidi Bone Marrow Biopsy/Aspiration Needle T-Handle Jamshidi Bone Marrow Biopsy and Aspiration Trays Safe-T PLUS Trays Jamshidi Evolve Bone Marrow Biopsy and Aspiration Trays BD Insyte Intravascular Catheter, BD Angiocath Intravascular Catheter, BD Intosyte, BD Introsyte Autoguard BD Nexiva Closed IV Catheter System with NearPort IV Access stopcock, IV, set PhaSeal: Connector Luer Lock, C35, C45 BD PosiFlush SP Syringe One Piece Sharps Collector BD Bifurcated Needle BD Perisafe EpiduralAnesthesia Tray SURGIPHOR BD Hypodermic Syringe set, administration, intravascular Set, administration, intravascular BD PhaSeal BD Syringe NRFit Slip PIVO Set, administration, intravascular Texium BD Interlink Syringe Cannula Set, administration, intravascular set, I.V., fluid transfer set, administration, intravascular PBBCS with Preattached Holder set, administration, intravascular LUER STUB ADAPTERS BD IV Start Pak BD PhaSeal PhaSeal Optima Infusion Clamp, M25-O BD Durasafe Plus! Epidural Lock CSE BD Cathena Safety IV Catheter BD Neoflon Pro Safety IV Catheter Tuohy McKesson IV Safety Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Cathete BD Male/Female Luer Lock Cap set, administration, intravascular BD PosiFlush E-Z SCRUB Bonanno Suprapubic Bladder Drainage BD Whitacre Spinal NRFit Needle Velano ExT Extension Set BD Perisafe Weiss Epidural Needle BD Perisafe Tuohy Epidural Needle Surgiphor BD Nexiva Closed IV Catheter System Breast Lesion Localization Needle Safe-T PLUS Safe-T-Centesis Thora-Para BD Intosyte Set, administration, intravascular Eclipse SmartSlip set, i.v. fluid transfer BD SafetyGlide Needle NEEDLE, ASPIRATION AND INJECTION, REUSABLE Glass LOR Syringe BD PhaSeal BD Blunt Filter Needle Set, administration, intravascular BD Texium Needle-Free Syringe Alcohol Swab set, administration, intravascular BD Hypodermic Syringe BD Durasafe Combined Anesthesia Kit BD PosiFlush SafeScrub Pudendal/Local Anesthesia Block Interlink Y Lock, Interlink Lever Lock Fast Track Tunneler Set set, administration, intravascular set, administration, intravascular Set, administration, intravascular set, administration, intravascular set, blood transfusion BD Insyte Autoguard BC Pro Shielded IV Catheter BD Insyte Autoguard Shielded IV Catheter BD Insyte Autoguard BC Shielded IV Catheter PleurX 42-4016, Introducer Kit BD Curve Ascites Shunt 42-4012, Introducer Kit Interlink Threaded Lock Cannula T-Handle Jamshidi Bone Marrow Biopsy and Aspiration Tray BD IV Start Pak BD Saf-T-Intima Subcutaneous Catheter System set, administration, intravascular set, administration, intravascular Velano Vascular Q2® Extension Set BD SmartSite 13mm Vial Access Device & BD SmartSite 20mm Vial Access Device set, administration, intravascular Set, administration, intravascular Vacutainer Needle Disposl Container TIVA BD PhaSeal set, administration, intravascular set, administration, intravascular PeritX 2L Drainage Starter Pack PeritX 2L Drainage Starter Tote PeritX Peritoneal Catheter System PeritX 2L Drainage Kit set, administration, intravascular BD Sharps Collectors SafetyLok Syringe BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero BD Nexiva Diffusics Closed IV Catheter System CORNWALL Eclipse Catheter Connector Nestable Sharps Collectors

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-07-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-07-13
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2022-07-13
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2022-07-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-07-13
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2022-07-13
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2023-08-02
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
LWE	Bone Marrow Collection/Transfusion Kit	Unknown	Class 2	N/A	2017-01-05
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-09-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-09-25
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2023-08-02
HEE	Set, Anesthesia, Paracervical	Obstetrics/Gynecology	Class 2	884.5100	2009-10-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2009-11-16
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2015-02-05
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-05-24
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2016-06-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2025-11-21
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2022-04-25
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2016-11-22
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-12-01
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2022-04-25
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-07-13
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2022-07-13
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2022-07-13
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2012-04-11
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2013-04-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-11-07
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2022-11-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-05-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-08-11
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2024-10-28
SCL	Allergen And Vaccine Delivery Needles	General Hospital	Class 2	880.5570	2022-07-13
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-07-13
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-07-13
DWD	Suction Control, Intracardiac, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4430	2022-07-13
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2020-11-13
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2026-03-03
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-03-03
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2022-07-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2014-03-31
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-07-13
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2022-07-13
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2022-07-13
HXG	Tamp	Orthopedic	Class 1	888.4540	2009-11-03
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2017-09-12
OJT	Aspiration Tray	General, Plastic Surgery	Class 1	878.4800	2019-04-15
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-05-24
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2009-10-12
FSH	Tray, Surgical, Needle	General, Plastic Surgery	Class 1	878.4800	2009-10-12
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-10-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-10-28
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2022-03-03
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2022-07-13
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2026-01-26
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-07-13
PWY	Lumbar Puncture Tray (Adult & Pediatric)	General Hospital	Class 2	880.5570	2019-04-15
SCL	Allergen And Vaccine Delivery Needles	General Hospital	Class 2	880.5570	2022-07-13
HIO	Sampler, Amniotic Fluid (Amniocentesis Tray)	Obstetrics/Gynecology	Class 1	884.1550	2009-10-12
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2022-07-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-10-17
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2022-10-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-07-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
MIA	Needle, Spinal, Short Term	Anesthesiology	Class 2	868.5150	2009-10-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2022-07-13
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2016-11-22
QEH	Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact	General Hospital	Class 2	880.5860	2022-07-13
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2022-04-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-03-03
HFX	Clamp, Circumcision	Obstetrics/Gynecology	Class 2	884.4530	2009-10-12
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-05-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-05-24
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2022-03-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-03-31
FKO	Catheter, Peritoneal Dialysis, Single Use	Gastroenterology, Urology	Class 2	876.5630	2009-10-12
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2022-07-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-07-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2019-12-20
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2023-05-16
MIA	Needle, Spinal, Short Term	Anesthesiology	Class 2	868.5150	2009-10-12
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2022-07-13
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2022-07-13
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2022-07-13
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2022-07-13
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-08-04
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2023-05-16
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-05-24
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-05-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-09-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2022-07-13
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2009-12-17
FEZ	Catheter And Tube, Suprapubic	Gastroenterology, Urology	Class 2	876.5090	2023-05-16
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2022-07-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-04-25
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2024-10-28
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2026-03-03
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-03-03
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-05-24
LWE	Bone Marrow Collection/Transfusion Kit	Unknown	Class 2	N/A	2009-10-12
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2022-07-13
PXI	Thoracentesis Tray	General Hospital	Class 2	880.5570	2019-04-15
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-07-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-07-13
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2022-03-03
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2009-10-12
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-07-13
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2009-11-10
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-05-16
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2022-07-13
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2022-07-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-02-02
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2024-02-02
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2022-07-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-07-13
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2022-07-13
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2022-07-13
QTI	Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device	General Hospital	Class 2	880.5200	2024-10-28
KNE	Set, Anesthesia, Obstetric	Obstetrics/Gynecology	Class 2	884.5100	2022-07-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-05-24
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2009-10-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2022-03-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-05-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	2022-03-03
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-09-30
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-09-30
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-04-11
KPM	Shunt, Peritoneal	Gastroenterology, Urology	Class 2	876.5955	2018-02-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-02-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-05-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-05-24
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2009-10-12
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2022-05-24
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-12-01
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
KPM	Shunt, Peritoneal	Gastroenterology, Urology	Class 2	876.5955	2009-10-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-03-31
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-04-25
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-04-02
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-03-31
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2022-07-13
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2022-04-25
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2022-07-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-03-31
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2025-01-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-03
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-07-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-07-13
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-06-27
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2022-08-29
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-07-13
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2022-07-13
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-07-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CAREFUSION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9680904	CareFusion D.R. 203 Ltd.	SANTO DOMINGO Distrito Nacional, DO
1625685	CAREFUSION 2200, INC.	Mannford, OK, US
3004932373	CareFusion 213 LLC	EL PASO, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1423507. Last updated year: 2026. Please use registration number 1423507 when referencing this establishment in official correspondence.