AEROBIOTIX USA

FDA Device Registration & Listing · Miamisburg, OH, US · Registration 3014151865

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
3014151865
FEI Number
3014151865
Entity Name
AEROBIOTIX USA
City/State/Country
Miamisburg, OH, US
Establishment Address
444 Alexandersville Rd, Miamisburg, OH 45342, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Aerobiotix USA (Owner Number: 10094028)
Owner / Operator Contact Address
444 Alexandersville Rd., Miamisburg, OH 45342, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K203189
PMA Number
N/A

All Registered Proprietary Names

AeroCure Vac Sterile Filter Drape AeroCure Vac Filter Drape AeroCure Vac Hose XL AeroCure-HUAIRS AeroCure Vac HEPA Filter Assembly ULPA Carbon F Filter AeroCure Vac

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2025-09-19
FRA Purifier, Air, Ultraviolet, Medical General Hospital Class 2 880.6500 2025-09-19

Official Correspondent

Michael Schmitz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Aerobiotix USA
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 3014151865. Last updated year: 2026. Please use registration number 3014151865 when referencing this establishment in official correspondence.
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