Data / Medical devices / United States / Pharmacaribe LLC
Pharmacaribe LLC: FDA-registered device maker in Naples, FL, United States, 4 510(k) clearances
Pharmacaribe LLC is registered with the FDA (registration 3006500694) in Naples, FL, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 13, 2013. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006500694
- Address
- 980 Palm View Drive #104, Naples, FL, United States, 34110
- Owner or operator
- Pharmacaribe LLC (10035899)
- Roles
- Specification developer
- First device listed
- March 31, 2011
- Registered through
- 2026
- Brand names listed
- Inhaled Saline Solutions, 3%, 3.5%, 6%, 7.5%, 10%, NESSI Rx, Nessi Spacer OTC, PulmoSal pH 7.4, 0.9%, 3%, 3.5%, 6%, 7%, 10%
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Nebulizer (Direct Patient Interface) | CAF | 2 | Specification developer | accessdata.fda.gov |
| Spacer, Direct Patient Interface | NVO | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 13, 2013 | K130091 | PULMOSAL | CAF | Substantially Equivalent | Pharmacaribe | accessdata.fda.gov |
| September 1, 2010 | K101532 | NESSI OTC SPACER | NVO | Substantially Equivalent | Pharmacaribe | accessdata.fda.gov |
| August 17, 2010 | K101424 | PHARMACARIBE INHALED SALINE SOLUTIONS | CAF | Substantially Equivalent | Pharmacaribe | accessdata.fda.gov |
| November 20, 2009 | K091862 | NESSI SPACER | NVO | Substantially Equivalent | Pharmacaribe | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 29, 2015 | 73053 | Class II | Terminated | PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebuli | Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+) | accessdata.fda.gov |
Compare with other makers
Updated February 10, 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.