BEARPAC MEDICAL, LLC

FDA Device Registration & Listing · Moultonborough, NH, US · Registration 3015715211

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015715211
FEI Number
3015715211
Entity Name
BEARPAC MEDICAL, LLC
City/State/Country
Moultonborough, NH, US
Establishment Address
124 WEST POINT RD, Moultonborough, NH 03254, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Bearpac Medical (Owner Number: 10061111)
Owner / Operator Contact Address
124 West Point Road, Moultonborough, NH 03254, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K190292
PMA Number
N/A

All Registered Proprietary Names

Passio Pump Drainage System Passio Pump Drainage System Passio

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2023-11-29
DWM Apparatus, Suction, Patient Care Cardiovascular Class 2 870.5050 2021-10-06
DWM Apparatus, Suction, Patient Care Cardiovascular Class 2 870.5050 2019-08-22

Official Correspondent

Jay Zimmerman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bearpac Medical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K160450 Care Fusion Pleurx Pleural Catheter System 2016-10-31

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3006950086 Merit Medical Nederland BV Maastricht Airport Limburg, NL
3015309643 Merit Medical UK Limited Earley Reading, GB
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015715211. Last updated year: 2026. Please use registration number 3015715211 when referencing this establishment in official correspondence.
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