ZEVEX, INC.
Registration 1722139FEI 1000117172Salt Lake City, UT
Owner/operator: MOOG, INC.
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Device in the United States for Export Only
- Manufacture Medical Device
- Manufacture Medical Device for Another Party (Contract Manufacturer)
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 14
- Added, last 12 months
- 2
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 14
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| PIF | ENFit Enteral Administration SetsGastrointestinal Tubes With Enteral Specific Connectors | Class 2 | 21 CFR 876.5980 | K142539 |
| HQE | NGPC Frag Handpiece; Stellaris PC Frag HandpieceInstrument, Vitreous Aspiration And Cutting, Ac-Powered | Class 2 | 21 CFR 886.4150 | — |
| HQE | Fragmentation; StellarisInstrument, Vitreous Aspiration And Cutting, Ac-Powered | Class 2 | 21 CFR 886.4150 | — |
| FRN | Pump, InfusionPump, Infusion | Class 2 | 21 CFR 880.5725 | K981816 |
| FRN | Curlin 8000 IV Infusion PumpPump, InfusionAdded Aug 11, 2026 | Class 2 | 21 CFR 880.5725 | K232793 |
| LZH | Pump, Infusion, EnteralGeneral Hospital | Class 2 | 21 CFR 880.5725 | K031199 |
| LZH | Abbott FreeGo Feeding pumpPump, Infusion, Enteral | Class 2 | 21 CFR 880.5725 | — |
| FPA | Curlin 8000 IV Infusion PumpSet, Administration, IntravascularAdded Aug 11, 2026 | Class 2 | 21 CFR 880.5440 | K232793 |
| HQC | Fragmentation; StellarisUnit, Phacofragmentation | Class 2 | 21 CFR 886.4670 | — |
| HQC | Veritas Swivel HandpieceUnit, Phacofragmentation | Class 2 | 21 CFR 886.4670 | — |
| HQC | NGPC Frag Handpiece; Stellaris PC Frag HandpieceUnit, Phacofragmentation | Class 2 | 21 CFR 886.4670 | — |
| KYG | SOVEREIGN CATARACT EXTRACTION SYSTEMDevice, Irrigation, Ocular Surgery | Class 1 | 21 CFR 886.4360 | — |
and 2 more on your full dossier
What changed
- Aug 11, 2026Listing added: FRN — Curlin 8000 IV Infusion Pump (K232793)
- Aug 11, 2026Listing added: FPA — Curlin 8000 IV Infusion Pump (K232793)