Data / Medical devices / Netherlands / Cardinal Health C/O Avarto Benelux BV
Cardinal Health C/O Avarto Benelux BV: FDA-registered device maker in Heijen Limburg, Netherlands, 8 510(k) clearances
Cardinal Health C/O Avarto Benelux BV is registered with the FDA (registration 3014656668) in Heijen Limburg, Netherlands. It lists 13 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 20, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014656668
- Address
- Brem 1, Heijen Limburg, Netherlands, 6598 MH
- Owner or operator
- Cardinal Health 200, LLC (9028292)
- Roles
- Exporter to the US
- First device listed
- August 1, 1995
- Registered through
- 2026
Devices it lists
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 |
| November 7, 2019 | K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit Connection | PIF | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| September 1, 2016 | K161963 | Monoject Enteral Syringe with ENFit Connector | PNR | Substantially Equivalent | Covidien | 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 |
| August 23, 1995 | K952945 | AQUAFLO HYDROGEL WOUND DRESSING & PACKER | NAE | Substantially Equivalent for Some Indications | Sherwood Medical Co. | accessdata.fda.gov |
| September 8, 1994 | K932295 | NON-BALLOON REPLACEMENT GASTROSTOMY KIT | KNT | Substantially Equivalent | Biosearch Medical Products, Inc. | accessdata.fda.gov |
| January 15, 1992 | K913784 | DOBBHOFF(R) SINGLE PASS PEG KIT | KNT | Unknown | Biosearch Medical Products, Inc. | accessdata.fda.gov |
| February 4, 1986 | K854547 | MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE | FMI | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Gastrointestinal Tubes With Enteral Specific Connectors
- All makers of Tube, Double Lumen For Intestinal Decompression And/Or Intubation
- All makers of Pump, Infusion, Enteral
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Electrode, Electrocardiograph
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
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.