Data / Medical devices / United States / Cardinal Health
Cardinal Health: FDA-registered device maker in Riverview, FL, United States, 13 510(k) clearances
Cardinal Health is registered with the FDA (registration 3011200334) in Riverview, FL, United States. It lists 9 device types. The FDA files 13 510(k) clearances under its listings, the newest dated April 3, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011200334
- Address
- 8322 Eagle Palm Drive, Riverview, FL, United States, 33578
- Owner or operator
- Cardinal Health 200, LLC (9028292)
- Roles
- Manufacturer, Repackager or relabeler, Reprocessor
- First device listed
- August 31, 2001
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Manufacturer, Reprocessor | accessdata.fda.gov |
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Device, Patient Transfer, Powered | FRZ | 2 | Manufacturer, Reprocessor | accessdata.fda.gov |
| Oximeter | DQA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pump, Infusion, Enteral | LZH | 2 | Manufacturer | accessdata.fda.gov |
| Scale, Stand-On, Patient | FRI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Manufacturer, Reprocessor | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | 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 |
|---|---|---|---|---|---|---|
| April 3, 2023 | K230028 | Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly | JOW | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| December 20, 2022 | K221603 | Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD );Kangaroo OMNI ENtelliSet 500ml (E5FD );Kangaroo OMNI Feeding Set 1000ml (B10FD );Kangaroo OMNI ENtelliSet 1000ml (E10FD );Kangaroo OMNI ENPlus Spike Set (BSPFD );Kangaroo OMNI ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI | LZH | Substantially Equivalent | Cardinal Health, LLC | accessdata.fda.gov |
| January 19, 2017 | K163620 | Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves | JOW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 23, 2016 | K163055 | Reprocessed Kendall SCD Express Foot Cuff | JOW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 14, 2016 | K161886 | Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| December 23, 2014 | K141479 | KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS | LZH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 11, 2013 | K131021 | PULSE OXIMETER | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| August 27, 2013 | K132360 | KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER | JOW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 31, 2012 | K120058 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Zhongshan Transtek Electronics Co., Ltd. | accessdata.fda.gov |
| May 22, 2006 | K060649 | GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000 | FLL | Substantially Equivalent | Tyco Healthcare Group LP | accessdata.fda.gov |
| May 5, 2004 | K040196 | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS | LZH | Substantially Equivalent | Tyco Healthcare/Kendall | accessdata.fda.gov |
| January 11, 2001 | K003313 | FILAC FAS TEMP ELECTRONIC THERMOMETER | FLL | Substantially Equivalent | The Kendall Company | accessdata.fda.gov |
| January 11, 1979 | K781517 | AUTOMATIC BLOOD PRESSURE DEVICE | DXN | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Infusion, Enteral
- All makers of Sleeve, Limb, Compressible
- All makers of Continuous Measurement Thermometer
- All makers of Scale, Stand-On, Patient
- All makers of Oximeter
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
Updated April 3, 2023. 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.