PRODUCTOS PARA EL CUIDADO DE LA SALUD

FDA Device Registration & Listing · NOGALES Sonora, MX · Registration 9611590

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9611590
FEI Number
1000237915
Entity Name
PRODUCTOS PARA EL CUIDADO DE LA SALUD
City/State/Country
NOGALES Sonora, MX
Establishment Address
CARRETERA INTERNACIONAL KM. 6.5, Terrazas Del Cid, NOGALES Sonora 84000, MX
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
C. R. Bard, Inc. (Owner Number: 2212754)
Owner / Operator Contact Address
1 Becton Drive, Franklin Lakes, NJ 07417, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Campbell Surprapubic Trocar and Cannula Bard Specimen Container and Kit Model 2012 (Urotrack) Temperature Sensing Foley Catheter Urinary Drainage Container with Preattached Foley Catheter and Kit Syringe Assist Irrigation System Bard Syringe Assist Irrigation Syst Bard Cunnigham Incontinence Clamp Bard Penile Clamp Sentrinex™ 3D Port Dressing Statlock Stabilization Device Accessory - Foam Strips Sensor Holder Wound Closure Tape Strips AllPoints™ Dressing Change Kit Bardex All-Silicone Temperature- Sensing Foley Catheter Lubri-Sil I.C. Temperature-Sensing Foley Catheter (offered in strips and trays) Reliacath Nelation Catheter Bard Malleable Tip Catheter Stylet "J" Guidewires Bard Nitinol Guidewires Hyrdo-Glide Guidewire Bard Van Buren Curve Catheter Style NiCore Nitinol Guidewires Bardex 9cm Latex Right Angle Drain Bard Heyman Nephrostomy Short Tip Bard Suprapubic Needle Adapter Bardex Heyman Nephrostomy Short Tip Councill Model Hollow Stylet Suprapubic Trocar and Cannula (Campbell Model) Concil Model Hollow Stylet Bardex I.C. Pediatric Foley Cath Magic3 Rubber Utility Catheter Bard Red Rubber Utility Catheter SureStep Intermittent Catheter Tray I.C. Foley Catheter with Urine Collection Container I.C. Foley Catheter AquaFil Foley Catheter with Syringe Foley Catheter with AquaFil Magic3 Touchless Hydrophilic Intermittent Catheter System (for Canada) SureStep Foley Tray System Bardex IC Complete Care (for Canada) Lubri-Sil I.C. Complete Care Urine Meter Foley Tray (for Canada) SureStep Foley Tray System Bardex I.C. Complete Care Foley Catheter (for Canada) SureStep Foley Tray System Lubri-Sil IC Complete Care (for Canada) Bard Intra-Abdominal Pressure Monitoring Device BARD INTRA-ABDOMINAL PR Vertus Foley Catheter SureStep Bard Nylon Catheter Plug Bard Catheter Plug and Cap Foley Catheters Drains, Balloon Inflation Funnel on Bard "C" Clamp for Occluding Tubes, Polyurethane Ureteral Disposable Forceps Nasogastric Sump Tube Dual Lumen, w Radiopaque Stripe Marks Align Introducers Fast Track Tunneler Set PelviSoft Introducers InSnare Introducers Whelan Moss T-Tubes (biliary catheter) Disposable Apron BARD CARDIOTHORACIC ADAPTOR Bardex Lubri-Sil I.C. Foley Cath Lubri-Sil I.C. Foley Catheter (offered in strips and trays) Eagle Inflation Device Latex Foley Catheter with 30cc Preformed Balloon Bardia Foley Catheter Bard Lubricath Foley Catheter Bard Dual Connector to 3.5 mm Plug 12' Monitor Cable Sensica UO System Bard CritiCore Plastic Catheter Bard Silicone Elastomer-Coated Latex Foley Catheter Silicone Ureteral Coil Stent with Figure Four End Fluoro-4 Silicone Ureteral Coil Stent Fluoro-4 Silicone Ureteral Stent Urinary Diversion Stent Bard Silicone Ureteral Stenting Coude Tip Temperature-Sensing Cath CritiCore (Coude) Foley Tray Emesis Basin Non-sterile Urine Collection Bag Pediatric & Infant Catheter Kit Rayon Balls Tracheal Suction Latex rubber Suction System Trach-Eze Closed Ventilation Bard Plastic Cath N Sleeve Bard Cath'N Sleeve with Solution Container Davol DeLee Tracheal Davol Tracheal Suction Catheter Bard Suction Catheter, DeLee Tracheal Bard Cath'N Sleeve Suction Kit Bard Catheter and Glove Suction Kit Davol Suction Catheter Bard Suction Catheter Bard Plastic Suction Catheter Davol Bronchial Aspirating Catheter Bard Tracheal Suction Tray Hydrogel-Coated Urethral Catheter Bard DigniShield Stool Management System ENFit Bard DigniShield Stool Management System Bard® DigniShield® Stool Management System Collection Bags Inlay Ureteral Stent with Hydroglid Inlay VersaFit Multilength Ureteral Inlay Uteral Stent Inlay VersaFit Ureteral Stent Bardex I.C. 4-Way Foley Catheter Connector Tubing Universal PVC Y-Connector Bard Davol ReliaVac PVC Drain Bard Urine Meter with Bag Urine Collection Meter Bardex Lubri-Sil 3-Way Foley Cathet Bardex Lubri-Sil I.C. Foley Cathete Bardex Silicone Foley Catheter Bardex Silicone Foley Catheter (offered in strips and trays) Bard AquaGuide Ureteral Access Shea AquaGuide Ureteral Access AQUAGUIDE-BARD AQUAGUIDE Bard Davol ReliVac Stainless Steel Trocar Bard Red Rubber Utility Catheter SureStep Intermittent Catheter Tray 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 Solution Container Bard Urethral Catheterization Tray SureStep Foley Tray System (for Canada) Bardex Lubricath Foley Catheter (for Canada) Preconnected Bardex Lubricath Catheter (for Canada) Bard Urine Meter Bladder Care Tray with Bardex Lubricath Foley Catheter (for Canada) SureStep Foley Tray System Bardex Lubricath Coude Foley Catheter (for Canada) Bard Urine Meter Foley Tray with Bardex Lubricath Foley Catheter (for Canada) Bard Foley Tray with Bard HydrophilicCoated Foley Catheter (for Canada) SureStep Foley Tray System Bard Lubricath Foley (for Canada) All-Silicone Foley Catheter Lubri-Sil Foley Catheter (offered in strips and trays) Lubri-Sil I.C. Foley Catheter (offered in strips and trays) Bardex Silicone Foley Catheter (offered in strips and trays) Hydrogel/Silver-Coated Foley Cath & Foley Tray (I.C.) Bardex I.C. Foley Catheter (offered in strips and trays) SureStep Foley Tray System Bard All Silicone Foley Catheter Tray (for Canada) SureStep Foley Tray System Bardex All Silicone Foley Catheter Tray (for Canada) Bard Foley Tray with Bardex All Silicone Foley Catheter (for Canada) Silastic Brand Foley Catheter Bard® Silastic® Foley Catheter Bile Bag BARD URODYNAMIC CATHETER Davol Silicone Sheath Sump Drain Inlay Optima Multi-Length Ureteral Stent Inlay Optima Ureteral Stent Hydrogel-Coated Foley Catheter Max-Blade Coagulating Resector Evacuator Ellik Evacuator Bard Ellik Bladder Evacuator Unisex Pre-Lubricated Urethral Catheter Kit, Rubber Urethral Catheter Bardex Double Pigtail Stent Bard Lubricious-Coated Ureteral Stent with Suture Coil Stent Bardex Double Pigtail Ureteral Stent with Suture Bard Fluoro-4 Silicone Ureteral Stent Ureteral Coil Stent with Figure Four End Bard Fecal Containment Device with Adhesive and Accessories BARDIC CYSTOSCOPIC IRRIGATION UNIT V-Max Roller Bar Electrodes Loc-Strap Bard Male External Catheter (OTC) Bard Infection Control Urinary Needleless Sample Port Control Fit Urine Collection Container - bag/urinary drainage unit Bard Deluxe Dispoz-A-Bag Drainage Bag (Leg Bag) Urinary Drainage Unit(urinary leg Urotrack Plus (Model 220) Bard Leg Bag Holder w/ accessories) Bed Bag SureStep Foley Tray System Add-A-Foley Catheter (for Canada) Bard Foley Catheterization Tray Uro-Prep Tray (for Canada) SureStep Foley Tray System Complete Care Add-A-Foley Catheter (for Canada) Bard Standard Latex Free Foley Tray without Catheter (for Canada) Bard Male External Latex Disposable Catheter Bardia Foley Catheter Insertion w/o Catheter with Lubricant in SureStep Intermittent Catheter Tray Bard® Universal Catheterization Tray Bardia Urethral Catheter Tray 5cc Balloon w/o Catheter w/o Catheter Foley Catheter Insertion Tray for 30cc Balloon w/o Catheter Bard Foley Catheterization Tray Bard Latex Urethral Catheter (Tieman Model) Coude Tip Bardia Red Rubber Intermittent Catheters

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FBM Cannula And Trocar, Suprapubic, Non-Disposable Gastroenterology, Urology Class 1 876.5090 2014-07-09
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2012-01-06
FFG Device, Urine Flow Rate Measuring, Non-Electrical, Disposable Gastroenterology, Urology Class 2 876.1800 2007-02-27
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2007-12-10
FHA Clamp, Penile Gastroenterology, Urology Class 1 876.5160 1994-03-18
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2008-08-29
MJC Catheter, Urological (Antimicrobial) And Accessories Gastroenterology, Urology Class 2 876.5130 2008-01-07
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2008-01-07
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2018-01-25
EZB Stylet For Catheter, Gastro-Urology Gastroenterology, Urology Class 1 876.5130 2007-03-14
QGC Suprapubic Catheter Accessories Gastroenterology, Urology Class 1 876.5100 2025-07-31
MJC Catheter, Urological (Antimicrobial) And Accessories Gastroenterology, Urology Class 2 876.5130 2007-12-07
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2007-12-07
MJC Catheter, Urological (Antimicrobial) And Accessories Gastroenterology, Urology Class 2 876.5130 2014-10-26
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2026-02-25
MJC Catheter, Urological (Antimicrobial) And Accessories Gastroenterology, Urology Class 2 876.5130 2018-01-25
PHU Intra-Abdominal Pressure Monitoring Device Unknown Class U N/A 2007-09-07
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2019-06-14
FFL Dislodger, Stone, Basket, Ureteral, Metal Gastroenterology, Urology Class 2 876.4680 1999-12-16
KNY Accessories, Catheter, G-U Gastroenterology, Urology Class 2 876.5130 2010-02-22
EYB Catheter, Ureteral, Gastro-Urology Gastroenterology, Urology Class 2 876.5130 2007-12-11
HTD Forceps General, Plastic Surgery Class 1 878.4800 2012-01-06
BSS Tube, Nasogastric Gastroenterology, Urology Class 2 876.5980 2011-12-07
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 1994-03-18
PTT Biliary Catheter For Irrigation And Contrast Injection, Exempt Gastroenterology, Urology Class 2 876.5010 2017-10-24
FYE Dress, Surgical General, Plastic Surgery Class 1 878.4040 2018-12-26
GCE Adaptor, Catheter General, Plastic Surgery Class 1 878.4200 2005-06-10
MJC Catheter, Urological (Antimicrobial) And Accessories Gastroenterology, Urology Class 2 876.5130 2007-12-07
KOE Dilator, Urethral Gastroenterology, Urology Class 2 876.5520 2008-02-13
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2007-12-07
OIE Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2019-08-07
EXS Urinometer, Electrical Gastroenterology, Urology Class 2 876.1800 2012-02-24
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2007-12-12
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2009-07-10
EZC Catheter, Coude Gastroenterology, Urology Class 2 876.5130 2007-03-14
FNY Basin, Emesis General Hospital Class 1 880.6730 2012-01-06
NNW Bag, Urine Collection, Leg, For External Use, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2009-03-13
FFH Collector, Urine, Pediatric, For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2007-02-27
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2012-01-06
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2007-02-27
EZC Catheter, Coude Gastroenterology, Urology Class 2 876.5130 2007-12-07
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2016-04-05
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2007-12-10
MJC Catheter, Urological (Antimicrobial) And Accessories Gastroenterology, Urology Class 2 876.5130 2007-12-07
GCD Connector, Catheter General, Plastic Surgery Class 1 878.4200 2007-02-27
EXR Urinometer, Mechanical Gastroenterology, Urology Class 2 876.1800 2007-03-14
MJC Catheter, Urological (Antimicrobial) And Accessories Gastroenterology, Urology Class 2 876.5130 2008-01-07
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2008-01-07
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2007-02-27
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2007-02-27
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2011-12-07
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2007-12-12
NZU Collector, Urine, Powered, Non Indwelling Catheter Gastroenterology, Urology Class 1 876.5250 2018-01-10
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2014-01-15
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2007-12-07
EZC Catheter, Coude Gastroenterology, Urology Class 2 876.5130 2018-07-25
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2007-12-07
MJC Catheter, Urological (Antimicrobial) And Accessories Gastroenterology, Urology Class 2 876.5130 2007-12-07
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2018-07-25
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2007-03-14
EXF Bag, Bile Collecting Gastroenterology, Urology Class 2 876.5010 2025-07-31
FEN Device, Cystometric, Hydraulic Gastroenterology, Urology Class 2 876.1620 2006-03-01
GBS Catheter, Ventricular, General & Plastic Surgery General, Plastic Surgery Class 1 878.4200 2008-04-01
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2007-02-27
EZC Catheter, Coude Gastroenterology, Urology Class 2 876.5130 2007-12-07
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2007-02-27
KQT Evacuator, Gastro-Urology Gastroenterology, Urology Class 2 876.4370 2007-02-27
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) Gastroenterology, Urology Class 2 876.5130 2026-06-08
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2007-12-10
EXB Collector, Ostomy Gastroenterology, Urology Class 1 876.5900 1995-06-21
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 1999-01-27
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2007-02-27
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2007-02-27
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2007-12-12

Official Correspondent

No official correspondent registered.

US Agent Details

Joni Anderson Email: joni.anderson@bd.com Phone: (480) 2662981

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
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04
K233013 Silq Technologies Corporation 2-Way 100% Silicone Cleartract Catheter 2024-01-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2023 Hobbs Medical, Inc. 2
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023 Hobbs Medical, Inc. 2
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191
Z-0004-2013 Cure Medical LLC 2
Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.
Z-0010-2013 C.R. Bard, Inc., Urological Division 2
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Z-0012-2023 Hobbs Medical, Inc. 2
Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611590. Last updated year: 2026. Please use registration number 9611590 when referencing this establishment in official correspondence.
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