Data / Medical devices / United States / ClensTech Inc.dba ASEPT PAK INC.
ClensTech Inc.dba ASEPT PAK INC.: FDA-registered device maker in Malone, NY, United States, 2 510(k) clearances
ClensTech Inc.dba ASEPT PAK INC. is registered with the FDA (registration 3007177643) in Malone, NY, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 13, 2013. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007177643
- Address
- 64 West Street, Malone, NY, United States, 12953
- Owner or operator
- Asept Pak Inc. (10024698)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- February 7, 2011
- Registered through
- 2026
- Brand names listed
- Nutrifill, PharmaCaribe PulmoSal PH7.4, 3%, 6%, 7% Nebusal, PulmoSal (pH+) 7%, pH 7.4
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lavage, Jet | FQH | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Products, Contact Lens Care, Rigid Gas Permeable | MRC | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| March 13, 2013 | K130091 | PULMOSAL | CAF | Substantially Equivalent | Pharmacaribe | accessdata.fda.gov |
| August 17, 2010 | K101424 | PHARMACARIBE INHALED SALINE SOLUTIONS | CAF | Substantially Equivalent | Pharmacaribe | accessdata.fda.gov |
Compare with other makers
- All makers of Lavage, Jet
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Products, Contact Lens Care, Rigid Gas Permeable
Updated March 13, 2013. 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.