FDA Registration
Active
🇺🇸 United States
ZEVEX, INC.
Reg #: 1722139
·
FEI: 1000117172
·
Expires 2026
Products
8
Proprietary Names
8
Establishment Types
4
Classifications
8
Registration Details
- Registration Name
- ZEVEX, INC.
- Registration Number
- 1722139
- FEI Number
- 1000117172
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4314 ZEVEX PARK LN.
- City
- Salt Lake City
- State
- UT
- ZIP
- 84123
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142539
Owner / Operator
- Firm Name
- MOOG, INC.
- Operator Number
- 9086921
- Address
- 4314 Zevex Park Lane
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84123
- Country
- US
- Correspondent
- Christopher Dodge
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2024-09-20 |
| Neurosurgical Ultrasonic Instruments | LBK | Class U | Unknown | No | 2024-09-20 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2013-06-27 |
| Pump, Infusion, Enteral | LZH | Class 2 | General Hospital | No | 2010-10-21 |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2015-04-16 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 1999-08-06 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2024-09-20 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | Class 2 | Ophthalmic | No | 2024-09-20 |
Proprietary Names
CUSA Clarity Handpiece
SOVEREIGN CATARACT EXTRACTION SYSTEM
Abbott FreeGo Feeding pump
ENFit Enteral Administration Sets
Pump, Infusion
NGPC Frag Handpiece; Stellaris PC Frag Handpiece
Veritas Swivel Handpiece
Fragmentation; Stellaris
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device