Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1125782

FEI Number

3002975287

Entity Name

MERIT MEDICAL SYSTEMS, INC

City/State/Country

Chester, VA, US

Establishment Address

12701 Kingston Avenue, Chester, VA 23836, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Merit Medical Systems, Inc. (Owner Number: 1721504)

Owner / Operator Contact Address

1600 West Merit Parkway, --, South Jordan, UT 84095, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

StayFix Fixation Device K12 Procedure Kit K19 Combination Packs K05 Inflation Kit K23C Vein Accessory Kit K22C Vein Tray K12T - Procedure Kit K05T - Inflation Kit 10Fore Hemostasis Valve Kit K02-00873A, K02-01105A, K02-01481A Sterilized Convenience Kits Revolution Catheter Securement Dev. K11 Pressure Monitoring Kit K17 Interventional Kit K09 Manifold Kit K17T - Interventional Kit K09T - Manifold Kit K20 Endoscopic Kit BRC-BAL-INT-FL/A K20T - Endoscopic Kit K12T-11465 OuTake Catheter Extractor Safety Paracentesis Tray (SPPT) Drainage Tubing Thoracentesis Tray (TAPS) Repositional Chest Tube RTT14038MB Brochoalveloar Lavage (BAL) Custom Convenience Kit K10 Waste Management Kit K10T - Waste Management Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2013-09-11
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2018-08-01
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2008-04-11
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2006-02-14
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2018-08-01
NWU	Endoscope Introducer Kit	Gastroenterology, Urology	Class 2	876.1500	2018-08-01
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2021-04-13
ODY	Tunneled Catheter Remover	General Hospital	Class 2	880.5970	2009-02-20
PYC	Paracentesis Tray	General, Plastic Surgery	Class 1	878.4200	2023-03-10
PXI	Thoracentesis Tray	General Hospital	Class 2	880.5570	2023-05-19
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2017-11-15
OYI	Non-Bronchoscopic Bronchoalveolar Lavage Catheter	Anesthesiology	Class 1	868.6810	2015-12-09
PPD	Universal Drainage Tray	Gastroenterology, Urology	Class 2	876.5130	2018-08-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Merit Medical Systems, 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
3021179744	VIEW POINT MEDICAL, INC.	Carlsbad, CA, US
3012276280	KA Medical	Arden Hills, MN, US
2032338	Merit Medical Systems, Inc.	ALISO VIEJO, CA, US
9615728	BIOSPHERE MEDICAL, S.A.	Roissy Val-d'Oise, FR
3010665433	Merit Medical Systems, Inc.	Houston, TX, 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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2017	Merit Medical Systems, Inc.	2	Merit Inflation Syringe Kit. Catalog Number KOS-02857
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-0027-2020	Merit Medical Systems, Inc.	2	Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1125782. Last updated year: 2026. Please use registration number 1125782 when referencing this establishment in official correspondence.