Data / Medical devices / United States / Aseptikits, LLC
Aseptikits, LLC: FDA-registered device maker in North Salt Lake, UT, United States, 4 510(k) clearances
Aseptikits, LLC is registered with the FDA (registration 3015422213) in North Salt Lake, UT, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 11, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015422213
- Address
- 101 North 700 West, North Salt Lake, UT, United States, 84054
- Owner or operator
- AseptiKits, LLC (10059956)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 6, 2020
- Registered through
- 2026
- Brand names listed
- ALAdrop Kit, EB 14 Custom Kit, Inline Infusion Filter, PALA 12 Kit, PALA 14 Kit, PALA 8 Kit, Solution Dropper Bottle, SyriKit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen, Sterile | FMH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Filter, Conduction, Anesthetic | BSN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Filter, Infusion Line | FPB | 2 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Repackager or relabeler | accessdata.fda.gov |
| System/Device, Pharmacy Compounding | NEP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 11, 2015 | K143583 | Cathivex ¿GV filter units | FPB | Substantially Equivalent | Merck Millipore , Ltd. | accessdata.fda.gov |
| March 27, 2014 | K133004 | VENTED MILLEX -GV, CATHIVEX -GV | BSN | Substantially Equivalent | Merck Millipore , Ltd. | accessdata.fda.gov |
| August 16, 2007 | K071459 | B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES | FMF | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 11, 1998 | K980987 | BECTON DICKINSON SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Filter, Conduction, Anesthetic
- All makers of Filter, Infusion Line
- All makers of System/Device, Pharmacy Compounding
- All makers of Container, Specimen, Sterile
Updated August 11, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.