FDA Registration
Active
🇺🇸 United States
Bard Access Systems, Inc.
Reg #: 3006260740
·
FEI: 3006260740
·
Expires 2026
Products
43
Proprietary Names
117
Establishment Types
4
Classifications
43
Registration Details
- Registration Name
- Bard Access Systems, Inc.
- Registration Number
- 3006260740
- FEI Number
- 3006260740
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 605 North 5600 West
- City
- Salt Lake City
- State
- UT
- ZIP
- 84116
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063240
Owner / Operator
- Firm Name
- C. R. Bard, Inc.
- Operator Number
- 2212754
- Address
- 1 Becton Drive
- City
- Franklin Lakes
- State
- NJ
- Postal Code
- 07417
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2007-10-22 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2011-01-04 |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | Class 2 | General Hospital | No | 2008-06-19 |
| Kit, Repair, Catheter, Hemodialysis | NFK | Class 2 | Gastroenterology, Urology | No | 2007-10-23 |
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2007-10-22 |
| Catheter, Hemodialysis, Triple Lumen, Non-Implanted | NIE | Class 2 | Gastroenterology, Urology | No | 2015-01-05 |
| Non-Stainless Steel Needle | PVZ | Class 2 | General Hospital | No | 2017-06-29 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2006-10-31 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2017-07-06 |
| Non-Coring (Huber) Needle | PTI | Class 2 | General Hospital | No | 2017-08-11 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2007-10-22 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2007-10-22 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2005-05-23 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2007-10-22 |
| Catheter, Hemodialysis, Non-Implanted | MPB | Class 2 | Gastroenterology, Urology | No | 2007-10-22 |
| Needle, Interosseous | MHC | Class 2 | General Hospital | No | 2021-03-09 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2024-10-14 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-10-14 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2024-09-20 |
| Catheter, Subclavian | LFJ | Class 2 | Gastroenterology, Urology | No | 2007-10-23 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2010-03-22 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2007-02-27 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 1994-03-18 |
| Subcutaneous Implanted Apheresis Port | PTD | Class 2 | General Hospital | No | 2019-08-13 |
| Central Venous Catheter With Manual Insertion System | SEF | Class 2 | General Hospital | No | 2025-04-23 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2014-03-28 |
| Dressing Change Tray | OXQ | Class 1 | General Hospital | No | 2016-02-26 |
| Clamp, Cannula | FKC | Class 1 | Gastroenterology, Urology | No | 2012-05-31 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 1999-04-14 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2013-05-10 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2011-12-07 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2008-08-29 |
| Midline Catheter | PND | Class 2 | General Hospital | No | 2017-06-02 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2014-01-09 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2014-01-23 |
| Tube, Gastro-Enterostomy | KGC | Class 2 | Gastroenterology, Urology | No | 2007-02-27 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2012-03-19 |
| Dilator, Vessel | FKA | Class 2 | Gastroenterology, Urology | No | 2007-10-22 |
| Bag, Bile Collecting | EXF | Class 2 | Gastroenterology, Urology | No | 2007-03-14 |
| Device, Vein Stabilization | LBJ | Class 1 | General Hospital | No | 2012-03-19 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2007-02-27 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 1999-12-16 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 1997-05-28 |
Proprietary Names
Sherlock
Ponsky Non-Balloon Replacement Gastrostomy Tube
PowerPort with Groshong Catheter
Titanium Low Profile Port
BardPort Titanium Ports
X-Port Low Profile Port
Per-Q-Cath
MidLine
Positioning System Stylet
Sherlock 3CG Tip Positioning System
Sensor & Sherlock 3CG Tip
Intravascular Catheter Securement Device
PowerPICC
Huber Plus
MRI Port
Soft-Cell Dual Lumen Catheter
Groshong PICC
Percutaneous Introducer Kit
Groshong
PowerLoc
Titanium PowerPort
HemoStar Long Term Hemodialysis Catheter
GlidePath Long Term Hemodialysis Catheter
HemoStar XK Long Term Hemodialysis Catheter
SlimPort MRI Ultra Low Profile Port
MRI Low Profile Port
Advance Introducer and SecureLoc Safety Introducer
SecureLoc
Niagara SlimCath
PowerGroshong
Titanium PowerPort isp
PowerPICC SV Catheter
BD Prevue II Peripheral Vascular Access System
PowerGlide Pro Midline Catheter
PowerGlide Pro Midline Catheter with Cue Needle Tracking System
Flexxicon
Brevia
VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER
Winged Infusion Set (WIS)
Non-Safety Needle
PowerLine
PowerHohn
MRI Hard Base Port
MRI PowerPort
Align Introducers
Fast Track Tunneler Set
PelviSoft Introducers
InSnare Introducers
PowerPort isp Implantable Port
PowerPort Slim Implantable Port
PowerPort M.R.I. Implantable Port
PowerPort M.R.I. isp Implantable Port
Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
SiteRite 9 Ultrasound System
Catheter Repair Kit with Replacement Connector
HemoGlide Star
HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
Vaccess
Alphacurve
HemoSplit
Site-Rite Needle Guide Kits and Pro
Hickman Trifusion
CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System
PowerPort ClearVUE isp Implantable Ports
PowerPort ClearVUE Slim Implantable Ports
PowerPort ClearVUE Slim Implantable Port
Catheter Plug
Navarre Universal Drainage Catheter
Navarre Opti-Drain Drainage Catheter
Bard Jejunal Tube
Gastrointestinal Tube
X-Port isp MRI Port
Bard Davol ReliVac Stainless Steel Trocar
Sentrinex 3D Port Dressing
Statlock Stabilization Device
Accessory - Foam Strips
Sensor Holder
Wound Closure Tape Strips
AllPoints Dressing Change Kit
SafeStep Huber Needle Set
PowerLoc Max Power Injectable Infusion Set
AccuCath Ace Intravascular Catheter
Titanium Port
Hohn
Broviac
Bard Extension Set
Per-Q-Cath Catheter Introducer
HemoStar
LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING (HemoStar, HemoSplit)
Poly Per-Q-Cath
Catheter System
Duet Long Term Hemodialysis
Bard Button Gastrostomy Tube
X-Port Duo MRI Port
Dilators
Dualator
Poly Per-Q-Cath PICC & Midline
HemoSplit XK
Groshong NXT
Dome Titanium Port
Niagara
Vaccess CT Low-Profile Power-Injectable Implantable Port
Vaccess CT Power-Injectable Implantable Port
PowerPort duo M.R.I. Implantable Port
Repair Kit
PowerPort duo MRI Implanted Port w/
9.5 Fr. DL Chronoflex Polyurethane
BD Intraosseous Vascular Access System EMS Powered Driver (D001003)
Vein Pick
Provena Midline Catheter
Rosenblatt Port
Cathlink 20 Titanium Port w/ Attachable Polyurethane Cathete
Soft-Cell
PowerHickman
X-Port Inline
X-Port duo Port
Groshong NXT ClearVue
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Device in the United States for Export Only