Data / Medical devices / United States / Bearpac Medical, LLC
Bearpac Medical, LLC: FDA-registered device maker in Moultonborough, NH, United States, 3 510(k) clearances
Bearpac Medical, LLC is registered with the FDA (registration 3015715211) in Moultonborough, NH, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 24, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015715211
- Address
- 124 West Point RD, Moultonborough, NH, United States, 03254
- Owner or operator
- Bearpac Medical (10061111)
- Roles
- Manufacturer, Specification developer
- First device listed
- August 22, 2019
- Registered through
- 2026
- Brand names listed
- Passio, Passio Pump Drainage System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Patient Care | DWM | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | PNG | 2 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| November 24, 2023 | K230319 | Passio Pump Drainage System | PNG | Unknown | Bearpac Medical | accessdata.fda.gov |
| November 20, 2020 | K201404 | Passio Pump Drainage System | DWM | Substantially Equivalent | Bearpac Medical | accessdata.fda.gov |
| July 25, 2019 | K190292 | Passio Pump Drainage System | DWM | Substantially Equivalent | Bearpac Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
- All makers of Apparatus, Suction, Patient Care
Updated November 24, 2023. 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.