AEROBIOTIX, INC.

AEROBIOTIX, INC.

Address:444 Alexandersville Rd.,Miamisburg,OH,45342,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Apparatus, Air Handling, Room (FZH) (5) Purifier, Air, Ultraviolet, Medical (FRA) (3) Drape, Surgical, Exempt (PUI) (2)

Premarket Exempt

No Yes

Clear

Illuvia - 00852348007117 Catalog Number :

Device Description : Air purification filter

Device Class : 2

Duns Number: 046659903

Premarket Exempt : Yes

Product Code : FZH

Prescription Use : No

Device Count : 1

Illuvia - 00852348007223 Catalog Number :

Device Description : Air purification filter

Device Class : 2

Duns Number: 046659903

Premarket Exempt : Yes

Product Code : FZH

Prescription Use : No

Device Count : 1

Illuvia - 00852348007292 Catalog Number :

Device Description : Air purification filter

Device Class : 2

Duns Number: 046659903

Premarket Exempt : Yes

Product Code : FZH

Prescription Use : No

Device Count : 1

Illuvia - 00852348007322 Catalog Number :

Device Description : Ultra-violet (C) germicidal lamp for air purification

Device Class : 2

Duns Number: 046659903

Premarket Exempt : Yes

Product Code : FZH

Prescription Use : No

Device Count : 1

Aerobiotix - 00852348007445 Catalog Number :

Device Description : Air purification pre-filter

Device Class : 2

Duns Number: 046659903

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Aerobiotix - 00852348007452 Catalog Number :

Device Description : Sterile air purification pre-filter

Device Class : 2

Duns Number: 046659903

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Aerobiotix - 00852348007551 Catalog Number :

Device Description : Air purification machine

Device Class : 2

Duns Number: 046659903

Premarket Exempt : No

Product Code : FRA

Prescription Use : No

Device Count : 1

Aerobiotix - 00852348007568 Catalog Number :

Device Description : Air purification HEPA Filter Assembly

Device Class : 2

Duns Number: 046659903

Premarket Exempt : Yes

Product Code : FRA

Prescription Use : No

Device Count : 1

Aerobiotix - 00852348007773 Catalog Number :

Device Description : Air purification machine

Device Class : 2

Duns Number: 046659903

Premarket Exempt : No

Product Code : FRA

Prescription Use : No

Device Count : 1

Illuvia - 00852348007889 Catalog Number :

Device Description : Air purification machine

Device Class : 2

Duns Number: 046659903

Premarket Exempt : Yes

Product Code : FZH

Prescription Use : No

Device Count : 1

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