Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006260740

FEI Number

3006260740

Entity Name

Bard Access Systems, Inc.

City/State/Country

Salt Lake City, UT, US

Establishment Address

605 North 5600 West, Salt Lake City, UT 84116, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

C. R. Bard, Inc. (Owner Number: 2212754)

Owner / Operator Contact Address

1 Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K030268

PMA Number

N/A

All Registered 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 PowerPICC 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 Alphacurve PowerPICC PowerLine PowerHohn 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 Sherlock 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 HemoSplit 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 Alphacurve HemoSplit XK Groshong NXT Dome Titanium Port Flexxicon Niagara

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2011-01-04
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-06-19
NFK	Kit, Repair, Catheter, Hemodialysis	Gastroenterology, Urology	Class 2	876.5540	2007-10-23
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-06-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-10-26
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-23
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2010-02-12
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2018-04-30
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-10-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2009-08-26
NIE	Catheter, Hemodialysis, Triple Lumen, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2015-01-05
PVZ	Non-Stainless Steel Needle	General Hospital	Class 2	880.5570	2017-06-29
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2006-10-31
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2016-06-14
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2017-07-06
PTI	Non-Coring (Huber) Needle	General Hospital	Class 2	880.5570	2017-08-11
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
NFK	Kit, Repair, Catheter, Hemodialysis	Gastroenterology, Urology	Class 2	876.5540	2010-01-29
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-10-22
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-23
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2010-01-29
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2007-02-27
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2012-06-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-10-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-10-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2005-05-23
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-10-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2021-03-19
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-10-22
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2022-05-16
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-23
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2008-08-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-05-19
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-10-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
MHC	Needle, Interosseous	General Hospital	Class 2	880.5570	2021-03-09
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-12-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-13
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2010-11-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-10-14
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-10-14
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-09-20
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2007-10-23
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2010-03-22
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-11
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2017-10-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-08-22
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-02-27
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2005-12-27
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-23
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-23
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1994-03-18
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2025-06-26
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2022-09-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-09-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-09-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-09-13
NIE	Catheter, Hemodialysis, Triple Lumen, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2015-06-19
NFK	Kit, Repair, Catheter, Hemodialysis	Gastroenterology, Urology	Class 2	876.5540	2010-09-08
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-10-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-04-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-04-15
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-10-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2015-11-19
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2007-10-23
PTD	Subcutaneous Implanted Apheresis Port	General Hospital	Class 2	880.5965	2019-08-13
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
SEF	Central Venous Catheter With Manual Insertion System	General Hospital	Class 2	880.5200	2025-04-23
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-09-08
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2007-10-22
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2014-03-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-10-22
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2007-10-22
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-10-22
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2025-01-29
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2016-02-26
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2012-12-11
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2014-10-30
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2020-02-10
FKC	Clamp, Cannula	Gastroenterology, Urology	Class 1	876.5540	2012-05-31
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2007-10-23
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2020-04-15
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	1999-04-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2011-11-16
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2021-08-18
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2007-11-27
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2013-05-10
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-12-13
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-10-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-23
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2011-12-07
NFK	Kit, Repair, Catheter, Hemodialysis	Gastroenterology, Urology	Class 2	876.5540	2010-01-29
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2009-03-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-10-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2008-08-29
PND	Midline Catheter	General Hospital	Class 2	880.5200	2017-06-02
PTI	Non-Coring (Huber) Needle	General Hospital	Class 2	880.5570	2024-12-10
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2011-09-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-09-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-03-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-01-09
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2010-01-29
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-01-10
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2014-01-23
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-10-14
PTD	Subcutaneous Implanted Apheresis Port	General Hospital	Class 2	880.5965	2017-04-19
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2018-08-15
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-23
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2011-08-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-08-22
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-10-22
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-10-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
NFK	Kit, Repair, Catheter, Hemodialysis	Gastroenterology, Urology	Class 2	876.5540	2009-06-09
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2009-06-09
PND	Midline Catheter	General Hospital	Class 2	880.5200	2016-06-28
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-12-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-12-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-12-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2012-07-10
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2012-07-10
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-11-08
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2019-10-03
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-11-22
KGC	Tube, Gastro-Enterostomy	Gastroenterology, Urology	Class 2	876.5980	2007-02-27
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-12-13
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-22
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2012-03-19
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-04-15
FKA	Dilator, Vessel	Gastroenterology, Urology	Class 2	876.5540	2007-10-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2012-04-10
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-10-22
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2010-01-29
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2015-11-19
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2009-03-13
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-10-22
EXF	Bag, Bile Collecting	Gastroenterology, Urology	Class 2	876.5010	2007-03-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2005-05-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2005-05-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-05-23
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-10-23
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-10-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

C. R. Bard, Inc.

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

View Entity Profile →

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Related 510(k) Records

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Z-0001-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
Z-0004-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0025-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.
Z-0026-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.
Z-0027-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006260740. Last updated year: 2026. Please use registration number 3006260740 when referencing this establishment in official correspondence.