Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016774528

FEI Number

3016774528

Entity Name

ABMRC LLC

City/State/Country

Eagan, MN, US

Establishment Address

860 Blue Gentian Road, Suite 200, Eagan, MN 55121, US

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

ABMRC LLC (Owner Number: 10071982)

Owner / Operator Contact Address

860 Blue Gentian Road, Suite 200, Eagan, MN 55121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231728

PMA Number

N/A

All Registered Proprietary Names

BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Adult Medium BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Adult Large BiWaze Clear Dual Lumen Breathing Circuit - Acute BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Child BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Adult Small BiWaze Clear System BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Infant BiWaze Clear Dual Lumen Breathing Circuit With Mouthpiece BiWaze Clear Dual Lumen Breathing Circuit With Trach Adapter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2024-08-07

Official Correspondent

Priyanka Paul

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABMRC LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016774528. Last updated year: 2026. Please use registration number 3016774528 when referencing this establishment in official correspondence.