Data / Medical devices / Ireland / Cardinal Health Ireland Manufacturing Limited
Cardinal Health Ireland Manufacturing Limited: FDA-registered device maker in TULLAMORE Offaly, Ireland, 2 510(k) clearances
Cardinal Health Ireland Manufacturing Limited is registered with the FDA (registration 9611018) in TULLAMORE Offaly, Ireland. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 20, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611018
- FEI number
- 3002808143
- Address
- Tullamore Business and Technology Park, TULLAMORE Offaly, Ireland, R35 H903
- Owner or operator
- Cardinal Health 200, LLC (9028292)
- Roles
- Manufacturer
- First device listed
- August 1, 1995
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 2 | Manufacturer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Infusion, Enteral | LZH | 2 | Manufacturer | 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 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 |
| May 5, 2004 | K040196 | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS | LZH | Substantially Equivalent | Tyco Healthcare/Kendall | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Infusion, Enteral
- All makers of Apparatus, Suction, Operating-Room, Wall Vacuum Powered
- All makers of Bottle, Collection, Vacuum
Updated December 20, 2022. 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.