Data / Medical devices / Tunisia / Cair Tunisie
Cair Tunisie: FDA-registered device maker in Kalaa Kebira Sousse, Tunisia, 6 510(k) clearances
Cair Tunisie is registered with the FDA (registration 3005458990) in Kalaa Kebira Sousse, Tunisia. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 9, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005458990
- Address
- Lot. No. 46 Zone Industrielle Kala Kebira, Kalaa Kebira Sousse, Tunisia, 4060
- Owner or operator
- Cair LGL (10055478)
- Roles
- Manufacturer
- First device listed
- September 6, 2017
- Registered through
- 2026
- Brand names listed
- Cair Drive, Neutraclear, CareFusion Neutraclear multi-fuse Extension Set with needle-free connector(s), Carefusion NeutraClear Needle-Free Connector, Carefusion NeutraClear Needle-free connector, Guerbet 150cm Straight Extension/Injection Line for CT & MRI, Nutricair Enteral-Enfit, Vesco Enteral Feeding Tube with ENFit in PVC, Vesco Pediatric Enteral Feeding Tube with ENFit in PU
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dispenser, Liquid Medication | KYX | 1 | Manufacturer | accessdata.fda.gov |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 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 |
|---|---|---|---|---|---|---|
| June 9, 2022 | K213258 | Nasogastric Feeding Tubes - ENFit Port - PVC | PIF | Substantially Equivalent | Cair Lgl | accessdata.fda.gov |
| November 2, 2021 | K210598 | Pediatric Nasogastric Feeding Tubes - Single ENFit Port | PIF | Substantially Equivalent | Cair Lgl | accessdata.fda.gov |
| September 1, 2017 | K171117 | Carefusion NeutraClear Needle-free connector (EL-NC1000) | FPA | Substantially Equivalent | Cair Lgl | accessdata.fda.gov |
| August 15, 2017 | K171118 | Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) | FPA | Substantially Equivalent | Cair Lgl | accessdata.fda.gov |
| July 31, 2017 | K171132 | Carefusion NeutraClear Needle-free connector | FPA | Substantially Equivalent | Cair Lgl | accessdata.fda.gov |
| March 20, 2014 | K133073 | CAIR DRIVE, NEUTRACLEAR | FPA | Substantially Equivalent | Cair Lgl | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Dispenser, Liquid Medication
- All makers of Gastrointestinal Tubes With Enteral Specific Connectors
Updated June 9, 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.