Data / Medical devices / United States / Salaera d.b.a Perma Pure
Salaera d.b.a Perma Pure: FDA-registered device maker in Lakewood, NJ, United States, 2 510(k) clearances
Salaera d.b.a Perma Pure is registered with the FDA (registration 2244684) in Lakewood, NJ, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 12, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2244684
- Address
- 1001 New Hampshire Avenue Unit B, Lakewood, NJ, United States, 08701
- Owner or operator
- Salaera, LLC d.b.a Perma Pure (2244684)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 18, 2013
- Registered through
- 2026
- Brand names listed
- O2asis Humidifier
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 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 |
|---|---|---|---|---|---|---|
| November 12, 2020 | K193411 | O2asis Personal Oxygen Humidifier | BTT | Substantially Equivalent | Perma Pure, LLC | accessdata.fda.gov |
| October 25, 1988 | K881264 | PERMA PURE NAFION TUBE DRYER-MODEL ME | CBQ | Substantially Equivalent | Perma Pure Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Updated November 12, 2020. 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.