Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025434453

FEI Number

3025434453

Entity Name

MDL SOLUTIONS INCORPORATED

City/State/Country

Hamel, MN, US

Establishment Address

705 Tower Drive, Hamel, MN 55340, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MDL Solutions Incorporated (Owner Number: 10086686)

Owner / Operator Contact Address

705 Tower Drive, Hamel, MN 55340, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Porto2 Vent Emergency CPAP Emergent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2022-12-02
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2022-12-02
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2022-12-02

Official Correspondent

Gregg Hohenstein

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MDL Solutions Incorporated

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
K862192	U.O. Equipment Co.	RESUSCITATOR MODELS 10400/10500/10600/10700/10800	1986-07-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2025	Mercury Enterprises, Inc. dba Mercury Medical	2	Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025434453. Last updated year: 2026. Please use registration number 3025434453 when referencing this establishment in official correspondence.