FDA Registration
Active
🇺🇸 United States
MOZARC MEDICAL US LLC
Reg #: 3030574705
·
FEI: 3030574705
·
Expires 2026
Products
17
Proprietary Names
39
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- MOZARC MEDICAL US LLC
- Registration Number
- 3030574705
- FEI Number
- 3030574705
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 15 Hampshire Street
- City
- Mansfield
- State
- MA
- ZIP
- 02048
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213602
Owner / Operator
- Firm Name
- Mozarc Medical US LLC
- Operator Number
- 10090982
- Address
- 15 Hampshire Street
- City
- Mansfield
- State
- MA
- Postal Code
- 02048
- Country
- US
- Correspondent
- Carol Ming
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Peritoneal, Long-Term Indwelling | FJS | Class 2 | Gastroenterology, Urology | No | 2024-07-29 |
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2024-07-29 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2024-07-29 |
| Catheter, Subclavian | LFJ | Class 2 | Gastroenterology, Urology | No | 2024-07-29 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2024-07-29 |
| Catheter, Hemodialysis, Triple Lumen, Non-Implanted | NIE | Class 2 | Gastroenterology, Urology | No | 2024-07-29 |
| Catheter, Hemodialysis, Non-Implanted | MPB | Class 2 | Gastroenterology, Urology | No | 2024-07-29 |
| Catheter, Hemodialysis, Implanted, Coated | NYU | Class 2 | Gastroenterology, Urology | No | 2024-07-29 |
| Catheter, Peritoneal Dialysis, Single Use | FKO | Class 2 | Gastroenterology, Urology | No | 2024-07-29 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2024-07-29 |
| Cannula, A-V Shunt | FIQ | Class 2 | Gastroenterology, Urology | No | 2024-07-29 |
| Kit, Repair, Catheter, Hemodialysis | NFK | Class 2 | Gastroenterology, Urology | No | 2024-07-29 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2024-07-29 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2024-07-29 |
| Accessories, A-V Shunt | KNZ | Class 2 | Gastroenterology, Urology | No | 2024-07-29 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2024-07-29 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2024-07-29 |
Proprietary Names
Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
Ritus Introducer Needle
Ritus Peritoneal Dialysis Catheter Kit
Chameleon PTA Balloon Catheter with Injection Port
Tandem-Cath Chronic Dual Catheter System Repair Kit
Ritus Peritoneal Dialysis Accessory
Permcath Pediatric Chronic Silicone Oval Catheter Kit
Ritus Peritoneal Dialysis Accessories
MAHURKAR Elite Acute Triple Lumen Catheters, Kits, and Trays
Permcath Pediatric Chronic Silicone Oval Catheter Tray
Permcath Chronic Silicone Oval Catheter
Palindrome HSI Chronic Catheter Kits and Sport Packs
Pull Apart Introducer Sets Add device listing
Palindrome RT Chronic Catheter Kit
Chameleon PTA Balloon
Palindrome Chronic Catheter Kits and Sport Packs
Ritus Peritoneal Dialysis Accessory Oval Pull Apart Set
Ritus Peritoneal Dialysis Accessory Titanium Connector
MAHURKAR Acute Triple Lumen Catheter, Kits, and Trays
Acute and Chronic Catheter Repair Kit
Mahurkar Acute Single Lumen Catheters and Kits
MAHURKAR Chronic Silicone Catheter Kits and Trays
Ritus Peritoneal Dialysis Accessory Extender
MAHURKAR Acute Dual Lumen Catheters, Kits, and Trays
MAHURKAR Acute Dual Lumen High Flow Catheter Kits and Trays
Ritus Peritoneal Dialysis Accessory 8 Fr Dilator
Ritus Dialysis Catheter Accessories
Tandem-Cath Chronic Dual Catheter System
Palindrome RT Repair Kit
MAHURKAR Acute High Pressure Triple Lumen Catheter, Kits, and Trays
Permcath Pediatric Dual Lumen Catheter Repair Kit
Mahurkar Acute Single Lumen Catheter Straight Extension 8 Fr/Ch (2.7 mm) x 15 cm
Palindrome Precision HSI Chronic Catheter Kits and Sport Packs
Ritus Faller Tunneling Trocar
Chameleon PTA Balloon Catheter
Ritus Presternal Peritoneal Dialysis Catheter Trays
Ritus J/Straight Stainless Steel Guidewire
Ritus 10 Fr Pull Apart Set
Ritus Peritoneal Dialysis Catheter And Kits
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility