Data / Medical devices / United States / Med One Equipment Services, LLC
Med One Equipment Services, LLC: FDA-registered device maker in Sandy, UT, United States, 12 510(k) clearances
Med One Equipment Services, LLC is registered with the FDA (registration 3013652261) in Sandy, UT, United States. It lists 5 device types. The FDA files 12 510(k) clearances under its listings, the newest dated December 1, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013652261
- Address
- 10712 S 1300 E, Sandy, UT, United States, 84094
- Owner or operator
- Med One Equipment Services (10054899)
- Roles
- Contract sterilizer, Repackager or relabeler
- First device listed
- May 10, 2017
- Registered through
- 2026
- Brand names listed
- B.Braun, CareFusion, Carefusion, Hospira, Medex, Sigma, The WoundPro® Control Unit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Contract sterilizer, Repackager or relabeler | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Oximeter | DQA | 2 | Contract sterilizer, Repackager or relabeler | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Contract sterilizer, Repackager or relabeler | accessdata.fda.gov |
| Pump, Infusion, Pca | MEA | 2 | Contract sterilizer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| December 1, 2016 | K150960 | WoundPro Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Pensar Medical, LLC | accessdata.fda.gov |
| May 7, 2014 | K133801 | BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY | FRN | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| July 1, 2009 | K083689 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM | FRN | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| October 20, 2005 | K051641 | ALARIS SYSTEM PC UNIT, MODEL 8001 | FRN | Substantially Equivalent | Cardinal Health, Alaris Products | accessdata.fda.gov |
| August 24, 2005 | K052052 | HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| December 10, 2004 | K043299 | MEDLEY PCA MODULE, MODEL 8120 | MEA | Substantially Equivalent | Alaris Medical Systems, Inc. | accessdata.fda.gov |
| April 30, 2004 | K040899 | MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP | FRN | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| February 9, 2004 | K031741 | MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 | CCK | Substantially Equivalent | Alaris Medical Systems, Inc. | accessdata.fda.gov |
| September 9, 2003 | K032233 | MEDLEY PCA MODULE, MODEL 8120 | MEA | Substantially Equivalent | Alaris Medical Systems, Inc. | accessdata.fda.gov |
| December 19, 2002 | K023264 | MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 | FRN | Substantially Equivalent | Alaris Medical Systems, Inc. | accessdata.fda.gov |
| June 8, 2001 | K010966 | MEDLEY SP02 MODULE, MODEL 8220 | DQA | Substantially Equivalent | Alaris Medical Systems, Inc. | accessdata.fda.gov |
| June 21, 1995 | K950419 | THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS | FRN | Substantially Equivalent | Imed Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- All makers of Pump, Infusion
- All makers of Pump, Infusion, Pca
- All makers of Oximeter
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
Updated December 1, 2016. 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.