FDA Registration
Active
🇺🇸 United States
MERIT MEDICAL SYSTEMS, INC
Reg #: 1125782
·
FEI: 3002975287
·
Expires 2026
Products
14
Proprietary Names
36
Establishment Types
3
Classifications
14
Registration Details
- Registration Name
- MERIT MEDICAL SYSTEMS, INC
- Registration Number
- 1125782
- FEI Number
- 3002975287
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 12701 Kingston Avenue
- City
- Chester
- State
- VA
- ZIP
- 23836
- Country
- US
Owner / Operator
- Firm Name
- Merit Medical Systems, Inc.
- Operator Number
- 1721504
- Address
- 1600 West Merit Parkway, --
- City
- South Jordan
- State
- UT
- Postal Code
- 84095
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2013-09-11 |
| Angiography/Angioplasty Kit | OEQ | Class 2 | Cardiovascular | No | 2018-08-01 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2008-04-11 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2006-02-14 |
| Cardiovascular Procedure Kit | OEZ | Class 2 | Cardiovascular | No | 2018-08-01 |
| Endoscope Introducer Kit | NWU | Class 2 | Gastroenterology, Urology | No | 2018-08-01 |
| Tunneled Catheter Remover | ODY | Class 2 | General Hospital | No | 2009-02-20 |
| Paracentesis Tray | PYC | Class 1 | General, Plastic Surgery | No | 2023-03-10 |
| Thoracentesis Tray | PXI | Class 2 | General Hospital | No | 2023-05-19 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2017-11-15 |
| Non-Bronchoscopic Bronchoalveolar Lavage Catheter | OYI | Class 1 | Anesthesiology | No | 2015-12-09 |
| Universal Drainage Tray | PPD | Class 2 | Gastroenterology, Urology | No | 2018-08-01 |
| Fluid Drainage Tray | PXU | Class 1 | General, Plastic Surgery | No | 2020-11-20 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2003-06-05 |
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
Pericardiocentesis Catheter Kit
ReSolve Non-Locking Drainage Catheter
ReSolve Locking Drainage Catheter
One-Step Centesis Catheter
FastBreak Connector
Cen-Step Centesis Catheter
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only