Medical Guardian

FDA UDI

Class II (US FDA UDI)

by Aerus LLC

Identity

Trade Name: Medical Guardian FDA UDI
Generic Name: High-efficiency filter air cleaner, mobile FDA UDI
Model / Reference: F170A FDA UDI

Identifiers

Primary DI / UDI-DI: 00860006514808 FDA UDI
510(k) Number: K201220 FDA UDI
FDA Product Code: FRA FDA UDI
GMDN Term: High-efficiency filter air cleaner, mobile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: High-efficiency filter air cleaner, mobile

Medical Guardian by Aerus LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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RGF-BioControls — RGF ENVIRONMENTAL GROUP, INC · Class II

Cleared under the same submission

K201220 also covers:

ActivePure Medical Guardian — ACTIVEPURE MEDICAL LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Aerus LLC

Sources (1)

FDA UDI 4fae0ee4-f102-4d9d-a2d9-7a6764e4595d 33 fields · synced Jun 6, 2026