MENDTRONIX, INC.

FDA Device Registration & Listing · San Diego, CA, US · Registration 3010844918

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
3010844918
FEI Number
3010844918
Entity Name
MENDTRONIX, INC.
City/State/Country
San Diego, CA, US
Establishment Address
1855 Dornoch Court, Suite 100, San Diego, CA 92154, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device
Owner / Operator
Mendtronix Inc. (Owner Number: 10053335)
Owner / Operator Contact Address
1855 Dornoch Court, Suite 100, San Diego, CA 92154, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Multiphze Enclosed Bladder Irrigation System - includes urinary drainage bag and drape HeartBeam AIMIGo System; HeartBeam System Burble

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2022-12-14
MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular Class 2 870.2800 2026-05-27
KAR Irrigator, Sinus Ear, Nose, Throat Class 1 874.4420 2024-05-07

Official Correspondent

Michael Ritter

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mendtronix Inc.
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
K791969 Medline Industries, Inc. DYNACOR STERILE CLOSED SYS. DRAINAGE BAG 1979-11-05

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010844918. Last updated year: 2026. Please use registration number 3010844918 when referencing this establishment in official correspondence.
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