Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013041594

FEI Number

3013041594

Entity Name

Dymax, Corp.

City/State/Country

Zelienople, PA, US

Establishment Address

141 Zehner School Rd, Zelienople, PA 16063, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Positioning System Stylet Sherlock 3CG Tip Positioning System Sensor & Sherlock 3CG Tip Arctic Sun Temperature Management System Vacora Vacuum Assisted Biopsy Sys Arctic Sun Cleaning Solution Bard Dual Connector to 3.5 mm Plug 12' Monitor Cable Sensica UO System Bard CritiCore Site-Rite Needle Guide Kits and Pro EnCor Breast Biopsy System - EnCor Probes, Drivers, and Accessories EnCor Breast Biopsy System Arctic Sun Stat Temperature Management System EnCor Ultra Breast Biopsy System and Accessories EnCor Enspire Breast Biopsy System and Accessories Vacuum Tubing Patient Tubing PureWick FEC Collection Canister PureWick Urine Collection Accessories Kit PureWick Urine Collection System PureWick MEC PureWick Male External Catheter PureWick Female External Catheter Arctic Sun Temperature Management System (Model 5000) Arctic Sun Stat Temperature Management System

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	2009-08-26
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
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2014-01-23
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2016-09-07
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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-11-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-11-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-11-21
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2009-01-08
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2020-10-28
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-01-09
EXS	Urinometer, Electrical	Gastroenterology, Urology	Class 2	876.1800	2012-02-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2010-03-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2010-03-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2010-03-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2010-03-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2007-10-23
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
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2010-08-27
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2020-06-17
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2011-09-01
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	Class 1	876.5250	2018-01-10
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	2005-05-23
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2025-12-04
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2025-08-01

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 →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1725056	MEDIVANCE, INC.	LOUISVILLE, CO, US
3006513822	Lutonix, Inc.	Tempe, AZ, US
1223089	DAVOL INC.	WOBURN, MA, US
3002504068	Bard European Distribution Center NV	Olen Antwerpen, BE
1213643	DAVOL INC., SUB. C.R. BARD, INC.	Warwick, RI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K971999	B.Braun Medical, Inc.	PERIPHERALLY INSERTED CENTRAL	1997-11-24
K951723	GE Medical Systems	GE B510 TRANSDUCER	1995-11-14
K903562	Diasonics, Inc.	CW DOPPLER 2.25 MHZ PROBE	1992-03-02
K945318	Tetra Corp.	TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA	1995-05-05
K231666	FUJIFILM Healthcare Americas Corporation	Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	2023-12-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.

Similar Registrations

Registration Number	Establishment Name	Location
1018233	C.R. BARD, INC.	COVINGTON, GA, US
1724474	Terumo BCT STERILIZATION SERVICES, Inc.	LAKEWOOD, CO, US
1000314502	ADVANTECH CORPORATION	Milpitas, CA, US
9612433	VYGON Germany GmbH	AACHEN North Rhine-Westphalia, DE
3030714660	SPECTRUM VASCULAR	White Plains, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013041594. Last updated year: 2026. Please use registration number 3013041594 when referencing this establishment in official correspondence.