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Aerobiotix

FDA UDI

Class II (US FDA UDI)

by Aerobiotix, Inc.

Identity

Trade Name
Aerobiotix FDA UDI
Generic Name
Surgical laminar airflow unit FDA UDI
Device Name
Air purification machine FDA UDI
Model / Reference
AeroCure-MD FDA UDI
Description
Air purification machine FDA UDI

Identifiers

Primary DI / UDI-DI
00852348007773 FDA UDI
510(k) Number
K203189 FDA UDI
FDA Product Code
FRA FDA UDI
GMDN Term
Surgical laminar airflow unit 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Surgical laminar airflow unit

Aerobiotix by Aerobiotix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical laminar airflow unit.

Cleared under the same submission

K203189 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aerobiotix, Inc.

Sources (1)

  • FDA UDI 4c6ffe64-2839-4fdd-bfb2-94b68fa1ff3d 35 fields · synced May 30, 2026