Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004519921

FEI Number

3005846326

Entity Name

TRI-STATE DE MEXICO, S. DE R.L. DE C.V.

City/State/Country

MEXICALI Baja California, MX

Establishment Address

Calzada Presidente Venustiano Carranza #301, DESARROLLO INDUSTRIAL COLORADO, MEXICALI Baja California 21397, MX

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Medline Industries, LP (Owner Number: 1824619)

Owner / Operator Contact Address

Three Lakes Drive, --, Northfield, IL 60093, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Retractor Flush Connector Centurion Medline Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectri Medline Branded Kits Centurion Branded Kits Centurion FORCEPS Medline General Surgery Tray Centurion Tracheobronchial suction catheter kit Laceration tray NAMIC CONTRAST MANAGEMENT SYSTEM; NAMIC CONTRAST CONTROLLER; NAMIC SQUEEZE CONTRAST CONTROLLER Medline Trach Brush Centurion Medline Centurion Standard Extension Sets Centurion SorbaView SorbaView OTC SiteGuard VersaDerm SorbaView SHEILD HOLDER, NEEDLE, GASTROENTEROLOGIC cement, bone, vertebroplasty PHANTOM XL INSULATED DILATORS Medline Cardiovascular Procedure Kits Centurion Kits VARIOUS SIZES AND STYLE Centurion NEURO SUCTION TUBING / STERILE Centurion Centurion Centurion Medline Integrated Arterial Catheter Centurion Centurion CirClamp Centurion WINGGUARD SORBAVIEW SHIELD HUBGUARD SECUREVIEW NAMIC CLOSED FLUID SYSTEMS; NAMIC CONTRAST REMOVAL VALVE; NAMIC FILLING STATION; NAMIC FILLING STATION PLUS; NAMIC FLUID Centurion

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2018-06-05
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2008-07-22
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2009-06-23
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2013-02-06
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-09-27
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2023-07-25
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-12-14
MAC	Decontamination Kit	General, Plastic Surgery	Class 1	878.4014	2008-06-17
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2020-01-31
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2006-12-27
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2019-09-17
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Unknown	Class 3	N/A	2019-09-17
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2001-08-21
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2006-12-27
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	2022-11-22
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-09-27
OFF	Central Venous Catheter Tray	Cardiovascular	Class 2	870.1140	2017-12-29
PXO	Bone Marrow Biopsy Tray	General, Plastic Surgery	Class 1	878.4800	2017-09-06
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2019-02-26
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2008-06-19
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2025-02-19
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2023-05-01
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2008-11-06
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2010-01-22
OES	Cardiac Catheterization Kit	Cardiovascular	Class 2	870.1200	2011-09-08
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2014-02-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-02-25
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2008-06-18
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2008-08-06
MLS	Labor And Delivery Kit	Obstetrics/Gynecology	Class 2	884.4530	2008-06-25
BWB	Forceps, Tube Introduction	Anesthesiology	Class 1	868.5780	2019-06-14
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2011-01-13
FHB	Hook, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2016-01-13
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2009-06-12
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2011-01-13
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-01-13
OFR	Tracheobronchial Suction Catheter Kit	Anesthesiology	Class 1	868.6810	2025-12-01
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2006-12-27
PKD	Laceration Tray	General, Plastic Surgery	Class 1	878.4014	2017-09-19
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2023-07-25
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2001-08-21
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2001-08-21
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2018-01-08
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2007-12-12
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2006-12-27
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2020-01-07
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2001-08-21
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2008-01-16
PYA	Liver Biopsy Kit	General, Plastic Surgery	Class 1	878.4800	2018-06-08
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2014-12-01
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2014-12-01
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2013-12-18
NXA	Tracheotomy Care Kit	Anesthesiology	Class 2	868.5800	2017-12-29
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2008-11-14
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2025-03-21
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-02-25
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2011-01-31
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2022-12-14
OFD	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2011-08-04
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-12-11
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2014-11-24
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2004-04-06
FKG	Tray, Start/Stop (Including Contents), Dialysis	Gastroenterology, Urology	Class 1	876.5820	2009-06-12
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2021-12-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-05-20
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2001-08-21
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-07
OGR	Ear, Nose, And Throat Surgical Tray	Ear, Nose, Throat	Class 1	874.4420	2010-01-14
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2001-08-21
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2010-02-01
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2024-04-19
NXZ	Dental Hygiene Kit	Dental	Class 1	872.6855	2009-06-15
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2020-03-05
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2012-05-16
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2016-12-13
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2016-12-13
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2008-06-25
OFX	General Purpose Dental Tray	Dental	Class 1	872.6640	2012-02-09
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2016-06-23
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2019-06-20
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2008-01-25
HGD	Applicator, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2004-04-06
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2006-12-27
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2001-08-21
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2011-01-13
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2010-01-06
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2011-01-13
HFX	Clamp, Circumcision	Obstetrics/Gynecology	Class 2	884.4530	2018-09-11
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2022-05-19
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2003-04-25
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2016-05-17
HFX	Clamp, Circumcision	Obstetrics/Gynecology	Class 2	884.4530	2008-01-16
OGQ	Ear Irrigation Kit	General Hospital	Class 1	880.6960	2008-02-20
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2008-07-29
LRQ	Tracheostomy And Nasal Suctioning Kit	Unknown	Class 1	N/A	2011-04-12
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2001-08-21
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-01-03
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2008-08-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-10-19
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2013-01-08
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2011-01-13
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2006-12-27
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2007-12-12
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2019-01-30
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2006-03-17
MCY	Wound Dressing Kit	General Hospital	Class 2	880.5075	2008-01-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2011-07-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-07-25
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2010-02-01
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2006-12-27

Official Correspondent

Stephanie Augsburg

US Agent Details

KAREN KOWALCZYK KOWALCZYK Business: Centurion Medical Products, LP Email: kkowalczyk@medline.com Phone: (517) 5465400

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
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K915301	Advance Medical Designs, Inc.	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	1992-12-11
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2020	Merit Medical Systems, Inc.	2	Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004519921. Last updated year: 2026. Please use registration number 3004519921 when referencing this establishment in official correspondence.