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RGF-BioControls

FDA UDI

Class II (US FDA UDI)

by Rgf Environmental Group, Inc

Identity

Trade Name
RGF-BioControls FDA UDI
Generic Name
High-efficiency filter air cleaner, stationary FDA UDI
Device Name
Isolation Room HEPA Filter Module with UV Lamps FDA UDI
Model / Reference
EXC7-UV FDA UDI
Description
Isolation Room HEPA Filter Module with UV Lamps FDA UDI

Identifiers

Primary DI / UDI-DI
00811095020145 FDA UDI
510(k) Number
K972064 FDA UDI
FDA Product Code
FRA FDA UDI
GMDN Term
High-efficiency filter air cleaner, stationary 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

Category: High-efficiency filter air cleaner, stationary

RGF-BioControls by Rgf Environmental Group, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as High-efficiency filter air cleaner, stationary.

Cleared under the same submission

K972064 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rgf Environmental Group, Inc

Sources (1)

  • FDA UDI 896c6a84-606a-4217-9a5f-de7a4218cdb2 34 fields · synced May 30, 2026