Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1722139

FEI Number

1000117172

Entity Name

ZEVEX, INC.

City/State/Country

Salt Lake City, UT, US

Establishment Address

4314 ZEVEX PARK LN., Salt Lake City, UT 84123, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MOOG, INC. (Owner Number: 9086921)

Owner / Operator Contact Address

4314 Zevex Park Lane, Salt Lake City, UT 84123, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CUSA Clarity Handpiece CUSA Clarity Handpiece SOVEREIGN CATARACT EXTRACTION SYSTEM Abbott FreeGo Feeding pump ENFit Enteral Administration Sets Pump, Infusion NGPC Frag Handpiece; Stellaris PC Frag Handpiece

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2024-09-20
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2024-09-20
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2024-09-20
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2024-09-20
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2013-06-27
LZH	Pump, Infusion, Enteral	General Hospital	Class 2	880.5725	2010-10-21
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2015-04-16
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	1999-08-06
LZH	Pump, Infusion, Enteral	General Hospital	Class 2	880.5725	2007-11-30
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2024-09-20
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2024-09-20

Official Correspondent

Christopher Dodge

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MOOG, 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
3008058400	Moog Costa Rica, SRL	Alajuela San Jose, CR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K060316	Fresenius Kabi Deutschland GmbH	COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS	2006-06-23
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30
K850183	Deltec Systems, Inc.	CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M	1985-03-13
K091915	Lenstec, Inc.	FLUID ISOLATION DEVICE	2009-10-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0332-2022	Covidien Llc	U	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Z-0006-2011	CareFusion Corporation	2	CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1722139. Last updated year: 2026. Please use registration number 1722139 when referencing this establishment in official correspondence.