Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024987598

FEI Number

3024987598

Entity Name

MCSC MEDICAL LLC

City/State/Country

Orlando, FL, US

Establishment Address

255 S Orange Ave Ste 104, Pmb 1085, Orlando, FL 32801, US

Establishment Type(s)

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

Owner / Operator

MCSC Medical LLC (Owner Number: 10086387)

Owner / Operator Contact Address

255 S Orange Avenue, Suite 104 PMB 1085, Orlando, FL 32801, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K944412

PMA Number

N/A

All Registered Proprietary Names

Breather Med

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2022-11-08

Official Correspondent

Mark Carbone

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MCSC Medical LLC

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
1526863	ICU Medical, Inc.	DUBLIN, OH, US
3002808458	VITALOGRAPH IRELAND LTD.	Co Clare, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024987598. Last updated year: 2026. Please use registration number 3024987598 when referencing this establishment in official correspondence.