Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004122598

FEI Number

3004122598

Entity Name

PRODUCTOS MEDLINE S.A. DE C.V.

City/State/Country

NUEVO LAREDO Tamaulipas, MX

Establishment Address

BLVD. WORLD TRADE CENTER NO.106, PARQUE INDUSTRIAL ORADEL, NUEVO LAREDO Tamaulipas 88285, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medline Industries, LP (Owner Number: 1417592)

Owner / Operator Contact Address

Three Lakes Drive, Northfield, IL 60093, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K903493

PMA Number

N/A

All Registered Proprietary Names

Unna Medline Elastic Bandage Unna-Z CURAD Threeflex Bandages Fourflex Medline Elastic Retention Netting CoFlex LF2 Medline Stockinette CoFlex Sure-Wrap Elastic Bandage ACCU-SORB Matrix Microtek Esmark TwoFlex Accu-Wrap Medline / CDS laparoscopy kit Medline / CDS CT biopsy tray (kit) Medline Medline Basin Kit Centurion Basin Kit Summit / Infinity OR towels Medline OR Towels Ultrasorbs Dry Sheets ORLocate Towels Medline Cotton Balls Medline Breathing Circuit Medline Adult Expandable Anesthesia Circuit Medline Wound Dressing Kit CURAD Naturals Medline Medline Catheter Plug and Drain Tube Protector Centurion Catheterization Kit Medline Catheterization Kit Medline Anesthesia Mask Eclipse Surgical Drape Medline Surgical Drape Medline Keyboard Cover Medline Band Bag Medline Set Up Cover Vari-Lens Lingeman Procept AKTORmed Microtek Patient Drapes Medline Dome Bag Convertors Vital Care Perfect Pouch OnLume Medline Poly-lined Drape Medline Poly-lined Fenestrated Drape Medline Equipment Cover Microtek Probe Cover Microtek Equipment Drapes Medline Medline Maternity Knit Underpants FitRight Cloth-Like Adult Incontinence Briefs FitRight Underwear FitRight Booster Pad FitRight ActivEdge Underwear FitRight EasyFlex Brief FitRight Extended Wear Underwear Medline Belted Briefs FitRight ActivEdge Male Guard FitRight ActivEdge Bladder Control Pads Medline Mesh Underpants Medline Laceration Tray Medline Surgical Shave Prep Tray Medline Convenience Trays & Kits CSTM Medline Double / Single Basin Trays Medline surgical kits/trays and CDS modules Medline UNITE Joint Prep Kit Medline/Konig Electrosurgical, Cutting & Coagulation & Accessories Medline Electrosurgical Pencil / Pad / Accessory Medline / Konig Razor, Surgical Carefusion Clipper Blade Medline Clipper Blade Medline Surgical Clipper Medline Razor BREATHING BAGS MEDLINE BAG, RESERVOIR - BTC Medline Total 1-Layer Silicone Catheter Tray with Urine Meter Medline Endo Tray Medline surgical kits/trays and CDS modules MEDLINE General surgery tray (kit) Medline / Eclipse / Aurora / Sirus surgical packs Convenience Trays & Kits CSTM Medline Proxima Medline Laceration Tray MEDLINE TRAY, SURGICAL - LRP Medline/Konig Surgical Tray 137075-Surgical SetUp CSTM Medline Count Sheet Holder Medline / CDS cardiac catheterization kit Signature Latex Essential Surgical Gloves Centurion Scissors Medline O/R Scissors Medline/Konig Scissors, General & Surgical Medline / CDS cardiac catheterization kit Medline Body Fluid Clean Up Kit Medline Suction Tubing Medline Extension Tubing Medline Liposuction Tubing Medline Non-Conductive Connecting Tubing Medline Suture Removal Tray 140928-Suture Removal Kit CSTM Medline Arm/Leg Elevated Foam Positioner Medline Sterile Foam Block Positioners Medline Knee/Body Positioning Strap Medline Jackson Table Kit Med-Glide Patient Positioning Sheet Comfort Touch Foam Frame Headrest Medline Arm Cradle Positioner Medline Patient Position Support Medline / CDS circumcision tray (kit) 147572-Sterile Circumcision Tray CSTM Medline / CDS biopsy tray or kit Medline Lumbar Puncture Tray 321236-Sterile Biospy CSTM Medline Disposable Tourniquet Medline Radial Compression Band Medline / CDS cesarean section kit (tray) Medline / Konig Catheter and Tip, Suction SUCTION CATHETERS DYNACOR - POOLE SUCTION TIP Ortho YANKAUER SUCTIONING INSTRUMENTS MEDLINE CATHETER AND TIP, SUCTION - JOL STERILE PHYSIOLOGICAL SALINE STERILE WATER Medline / CDS maternity kit MEDLINE Labor and Delivery Kit - MLS Medline / Konig Speculum, Vaginal, Metal ST.PEDERSON VAGINAL SPECULUM MEDLINE / CENTURION STERILE GRAVES VAGINAL SPECULUM MEDLINE / CENTURION STERILE VAGINAL SPECULUM MEDLINE / CDS PLASTIC SURGERY KIT AND ACCESSORIES ANESTHESIA CIRCUIT Medline Pelvic Exam Kit Medline Tracheobronchial Suction Catheter Kit Medline D407 Series Sleeved Suction Catheter Kit Medline Suction Catheter Mini Tray Medline D409 Series Suction Catheter Kit Medline Suction Catheter Kit Medline Gastric Sump Tube Medline General Purpose Dental Tray Two-Toned Bonded Sterilization Wrap Gemini Sterilization Wrap Medline Medicine Cup Medline Triangular Graduate Container Medline Chest Drainage Kit PleuraGuide Disposable Chest Tube Kit / Tray Medline Endo Kit Medline Endoscope Introducer Kit SensiCare Sterile Power-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Vera SensiCare PI Green Medline / CDS gynecological laparoscopic kit (tray) Medline Chemo Spill Kit Centurion / Medline Central Line Pack Medline Humidifier Nebulizer Kit Gibeck Humid-Flo and Passive Kits Aquapak Humidifier Reservoir with Adaptor ISO GARD Breathing Circuit Kit Hudson RCI Conventional Breathing Circuit with Filter Aquapak Nebulizer Reservoir with Adaptor Oxygen Therapy Start-Up Kit Hudson RCI Circuit / Column Kits Comfort Flo Humidification System Hudson RCI Conventional Breathing Circuit with Nebulizer Medline / Konig Tray, Surgical, Instrument Medline Mayo Stand Medline Magnetic Instrument Mat Medline / CDS surgical instrument tray MedFix EZ Sorbaview Polar Dressing CURAD SureSite Roll Medline Bordered Gauze Gentac EZ MedFix StickRight CURAD Naturals Stickright Pinc anesthesia conduction kit; Pain Tray Sensicare PI Ortho Sensicare PI Green with Aloe Medline limb cover Medline Trach Kit Medline Tracheotomy Care Tray Unna-Z Medline Formtex Undercast Padding Wytex Undercast Padding Medline Undercast Padding Medline Casting Tape Syn-Tex Undercast Padding Unna Kit Medline Soft Casting Tape Medline Precut Splint Medline Wytex Undercast Padding Medline Plaster Casting Roll Medline / CDS nuerological tray (kit) Medline CURAD Medline Cath Kit MEDLINE Eye tray Medline Urinal Microtek MEDLINE LABEL OR TAG, STERILE Medline / CDS epidural anesthesia kit (tray) Medline / Konig Holder, Needle, Gastroenterologic Medline Baumgartner Needle Holder Suresite IV Slide Catheter Medline Needle Counter Medline Dialysis Tray Medline Access Care Kit Triumph LT Surgical Gloves NAMIC Fluid Delivery Set NAMIC Protection Station NAMIC Sosa Spike NAMIC Fluid Administration Set NAMIC Closed Fluid Systems NAMIC Filling Station NAMIC Filling Station Plus NAMIC Contrast Removal Valve NAMIC Protection Station Plus Triumph Surgical Gloves Triumph Micro Surgical Gloves Triumph LT Surgical Gloves DYNACOR CONTAINERS Medline/Centurion Sterile Bowl, Sterile Pitcher Medline Pathology Container Centurion Pathology Container Medline Midstream Collection Kit Medline Specimen Container NAMIC Contrast Management System NAMIC Contrast Controller NAMIC Squeeze Contrast Controller

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2020-03-02
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-03-02
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2005-02-01
FDE	Laparoscopy Kit	Gastroenterology, Urology	Class 2	876.1500	2010-08-09
OFG	Ct Biopsy Tray	Cardiovascular	Class 2	870.4075	2010-08-09
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	1991-12-30
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	1996-09-24
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2006-04-11
MCY	Wound Dressing Kit	General Hospital	Class 2	880.5075	2008-07-10
OJJ	Burn Kit Without Drug	General, Plastic Surgery	Class 1	878.4022	2011-09-15
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-01-30
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2006-04-11
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-25
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2010-11-10
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	1992-01-01
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	1979-05-15
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2008-11-20
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2008-11-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-05-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-05-16
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-11-18
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2006-04-11
PPB	Foley Catheter Kit (Excludes Hiv Testing)	Gastroenterology, Urology	Class 2	876.5130	2021-09-21
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2019-02-28
PKD	Laceration Tray	General, Plastic Surgery	Class 1	878.4014	2015-12-09
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	1991-12-30
OES	Cardiac Catheterization Kit	Cardiovascular	Class 2	870.1200	2008-07-09
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2021-10-15
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-10-05
OES	Cardiac Catheterization Kit	Cardiovascular	Class 2	870.1200	2008-07-09
OKG	Body Fluid Clean Up Kit	General, Plastic Surgery	Class 2	878.4040	2015-12-24
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2013-01-11
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2015-12-09
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2009-01-16
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2011-09-15
OHG	Circumcision Tray	Obstetrics/Gynecology	Class 2	884.4530	2010-08-09
FCH	Tray, Biopsy, Without Biopsy Instruments	Gastroenterology, Urology	Class 1	876.4730	1997-06-13
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2005-02-01
OHM	Cesarean Section Tray	Obstetrics/Gynecology	Class 2	884.1720	2008-07-09
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2005-02-01
MLS	Labor And Delivery Kit	Obstetrics/Gynecology	Class 2	884.4530	2008-07-09
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2015-03-31
FTN	Plastic Surgery And Accessories Kit	General, Plastic Surgery	Class 1	878.3925	2011-09-15
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2012-12-17
MLT	Pelvic Exam Kit	Obstetrics/Gynecology	Class 2	884.4530	2016-05-13
OFR	Tracheobronchial Suction Catheter Kit	Anesthesiology	Class 1	868.6810	2008-07-09
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2014-02-11
OFX	General Purpose Dental Tray	Dental	Class 1	872.6640	2016-04-15
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2013-02-21
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	1977-12-29
PAD	Chest Drainage Kit	General Hospital	Class 2	880.6740	2015-12-24
NWU	Endoscope Introducer Kit	Gastroenterology, Urology	Class 2	876.1500	2015-12-16
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2024-04-18
OHD	Gynecological Laparoscopic Kit	Obstetrics/Gynecology	Class 2	884.1720	2011-09-15
PWT	Chemotherapy Spill Clean-Up Kit	General Hospital	Class 1	880.6250	2020-01-17
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	1987-03-30
OGG	Humidifier Nebulizer Kit	Anesthesiology	Class 2	868.5450	2016-06-03
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1995-06-05
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2000-02-07
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2016-08-11
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-03-25
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2025-03-25
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-11-19
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2020-11-19
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	1987-03-30
NXA	Tracheotomy Care Kit	Anesthesiology	Class 2	868.5800	2008-07-09
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2014-05-02
OJG	Neurological Tray	Neurology	Class 1	882.4525	2010-08-09
FOB	Bedpan	General Hospital	Class 1	880.6730	2006-03-21
PXC	Personal Protection Kit	General Hospital	Class 1	880.6250	2026-04-23
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2010-08-09
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2010-08-09
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2005-02-01
FNP	Urinal	General Hospital	Class 1	880.6730	1991-12-30
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2011-09-03
OGE	Epidural Anesthesia Kit	Anesthesiology	Class 2	868.5120	2008-07-09
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2015-03-31
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2023-07-19
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2014-08-19
PEV	Dialysis Administration Kit	Gastroenterology, Urology	Class 2	876.5820	2015-01-20
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2010-06-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-11-04
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2015-10-27
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	1992-01-09
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2019-11-04

Official Correspondent

Stephanie Augsburg

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

Medline Industries, LP

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007128716	Medline Industries, LP	Norristown, PA, US
3036706541	EXCELSIOR MEDICAL LLC	Tinton Falls, NJ, US
3016073670	Medline Logistics Japan G.K.	Nishihocho, Aisai-shi Aichi, JP
3006581049	MICROTEK MEDICAL MALTA LIMITED	Mosta, MT
3010389834	Microtek Medical B.V. Varsseveld	VARSSEVELD Gelderland, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K002933	Maxxim Medical	STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES	2000-10-19
K913402	Smith & Nephew Perry	PERRY(R) DERMAGUARD(R) PLUS GLOVES	1991-10-02
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120
Z-0037-04	VIASYS Med Systems	1	Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004122598. Last updated year: 2026. Please use registration number 3004122598 when referencing this establishment in official correspondence.