FDA Registration
Active
🇺🇸 United States
CAREFUSION 2200, INC.
Reg #: 1423507
·
FEI: 3008002452
·
Expires 2026
Products
64
Proprietary Names
156
Establishment Types
2
Classifications
64
Registration Details
- Registration Name
- CAREFUSION 2200, INC.
- Registration Number
- 1423507
- FEI Number
- 3008002452
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 75 North Fairway Drive
- City
- Vernon Hills
- State
- IL
- ZIP
- 60061
- Country
- US
Regulatory Submissions
- 510(k) Number
- K021475
Owner / Operator
- Firm Name
- CAREFUSION
- Operator Number
- 10030506
- Address
- 75 N Fairway Dr
- City
- Vernon Hills
- State
- IL
- Postal Code
- 60061
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2022-07-13 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2022-07-13 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2022-07-13 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2022-07-13 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2022-07-13 |
| Infusion Safety Management Software | PHC | Class 2 | General Hospital | No | 2022-07-13 |
| Container, I.V. | KPE | Class 2 | General Hospital | No | 2023-08-02 |
| Bone Marrow Collection/Transfusion Kit | LWE | Class 2 | Unknown | No | 2017-01-05 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2025-09-25 |
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | Class 2 | General Hospital | No | 2023-08-02 |
| Set, Anesthesia, Paracervical | HEE | Class 2 | Obstetrics/Gynecology | No | 2009-10-12 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2009-11-16 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2015-02-05 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2016-06-28 |
| Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | PNG | Class 2 | Gastroenterology, Urology | No | 2016-11-22 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2022-07-13 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2022-07-13 |
| Apparatus, Suction, Patient Care | DWM | Class 2 | Cardiovascular | No | 2012-04-11 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2013-04-11 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2022-11-07 |
| Allergen And Vaccine Delivery Needles | SCL | Class 2 | General Hospital | No | 2022-07-13 |
| Suction Control, Intracardiac, Cardiopulmonary Bypass | DWD | Class 2 | Cardiovascular | No | 2022-07-13 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2026-03-03 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2026-03-03 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2022-07-13 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2022-07-13 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2022-07-13 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2009-11-03 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2017-09-12 |
| Aspiration Tray | OJT | Class 1 | General, Plastic Surgery | No | 2019-04-15 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2009-10-12 |
| Tray, Surgical, Needle | FSH | Class 1 | General, Plastic Surgery | No | 2009-10-12 |
| Saline, Vascular Access Flush | NGT | Class 2 | General Hospital | No | 2026-01-26 |
| Lumbar Puncture Tray (Adult & Pediatric) | PWY | Class 2 | General Hospital | No | 2019-04-15 |
| Sampler, Amniotic Fluid (Amniocentesis Tray) | HIO | Class 1 | Obstetrics/Gynecology | No | 2009-10-12 |
| Needle, Spinal, Short Term | MIA | Class 2 | Anesthesiology | No | 2009-10-12 |
| Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact | QEH | Class 2 | General Hospital | No | 2022-07-13 |
| Clamp, Circumcision | HFX | Class 2 | Obstetrics/Gynecology | No | 2009-10-12 |
| Catheter, Peritoneal Dialysis, Single Use | FKO | Class 2 | Gastroenterology, Urology | No | 2009-10-12 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2019-12-20 |
| I.V. Start Kit | LRS | Class 2 | General Hospital | No | 2023-05-16 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2022-07-13 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2022-05-24 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2009-12-17 |
| Catheter And Tube, Suprapubic | FEZ | Class 2 | Gastroenterology, Urology | No | 2023-05-16 |
| System, X-Ray, Mammographic | IZH | Class 2 | Radiology | No | 2022-07-13 |
| Thoracentesis Tray | PXI | Class 2 | General Hospital | No | 2019-04-15 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2009-10-12 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 2009-11-10 |
| Filter, Infusion Line | FPB | Class 2 | General Hospital | No | 2022-07-13 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2022-07-13 |
| Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device | QTI | Class 2 | General Hospital | No | 2024-10-28 |
| Set, Anesthesia, Obstetric | KNE | Class 2 | Obstetrics/Gynecology | No | 2022-07-13 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2009-10-12 |
| Set, Blood Transfusion | BRZ | Class 2 | General Hospital | No | 2022-03-03 |
| Shunt, Peritoneal | KPM | Class 2 | Gastroenterology, Urology | No | 2018-02-07 |
| Container, Sharps | MMK | Class 2 | General Hospital | No | 2022-07-13 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2022-08-29 |
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2022-07-13 |
| Heparin, Vascular Access Flush | NZW | Class 2 | General Hospital | No | 2022-07-13 |
| Cap, Device Disinfectant | QBP | Class 2 | General Hospital | No | 2022-07-13 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2011-12-16 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2022-07-13 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2012-11-21 |
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
BD Reusable Stopcocks and Adaptors
BD Nexiva Diffusics Closed IV Catheter System
HEIMLICH CHEST DRAIN VALVE
BD Phaseal Optima spike Set (C180-O)
BD PhaSeal Optima Connecting Set (C83-O)
PIVO
PIVO Pro Needle-free Blood Collection Device
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
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
BD PhaSeal
BD Syringe NRFit Slip
BD Interlink Syringe Cannula
set, I.V., fluid transfer
PBBCS with Preattached Holder
LUER STUB ADAPTERS
BD IV Start Pak
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
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
Breast Lesion Localization Needle
Safe-T PLUS
Safe-T-Centesis
Thora-Para
BD Intosyte
Eclipse SmartSlip
set, i.v. fluid transfer
BD SafetyGlide Needle
NEEDLE, ASPIRATION AND INJECTION, REUSABLE
Glass LOR Syringe
BD Blunt Filter Needle
BD Texium Needle-Free Syringe
Alcohol Swab
BD Durasafe Combined Anesthesia Kit
BD PosiFlush SafeScrub
Pudendal/Local Anesthesia Block
Interlink Y Lock, Interlink Lever Lock
Fast Track Tunneler Set
set, blood transfusion
BD Insyte Autoguard BC Pro Shielded IV Catheter
BD Insyte Autoguard Shielded IV Catheter
BD Insyte Autoguard BC Shielded IV Catheter
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 Saf-T-Intima Subcutaneous Catheter System
Velano Vascular Q2® Extension Set
BD SmartSite 13mm Vial Access Device & BD SmartSite 20mm Vial Access Device
Vacutainer Needle Disposl Container
TIVA
PeritX 2L Drainage Starter Pack
PeritX 2L Drainage Starter Tote
PeritX Peritoneal Catheter System
PeritX 2L Drainage Kit
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
BD Hypoint
BD PosiFlush Heparin
Twinpak
BD Biopsy Needles
BD Alaris Pump Infusion Set
BD Eclipse" Hypodermic Needle
Safe-T PLUS Tray
Illinois Bone Marrow Aspiration Tray
Illinois Bone Marrow Aspiration Needle
T-Handle Illinois Bone Marrow Aspiration Needle
T-Handle Illinois Bone Marrow Aspiration Tray
Eclipse Needle
BD SafetyGlde Insulin Syringe
BD 1mL Luer-Lok" Hypodermic Syringe
Heparin Lock Flush Solution, USP- BD PosiFlush" Heparin Lock Flush Syringe
BD Epilor Syringe
BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector
BD Flu+
BD Saf-T-Intima
set, i.v., fluid transfer
Nexiva IV Catheter
PureHub" Disinfecting Cap
BD ORAL SYRINGES
Introducer
BD Oral/Enteral Syringe
Catheter Adapter
BD Single Use, Hypodermic Syringe
Interlink Vial Access Cannula
BD PhaSeal Protector - P55
Connecta Stopcock IV Set
Neuro Surgical Clipper Blade
Surgical Clipper Charging Adapter
Surgical Clipper Blade
Surgical Clipper
SensiClip
Posiflush SF
BD Cathena" Safety IV Catheter
Axillary Block Needle
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility