UNOMEDICAL, INC.

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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

Ventilator, Emergency, Manual (Resuscitator) (BTM) (3)

Premarket Exempt

Clear

Hospitak, Mouth to Mask Resuscitator with Filter Adult Large Mask - 00084424900334 Catalog Number : 1059-E

Device Description : Hospitak, Mouth to Mask Resuscitator with Filter Adult Large Mask

Device Class :

Duns Number: 030271837

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask - 00084424900573 Catalog Number : 1055-E

Device Description : Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask

Device Class :

Duns Number: 030271837

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Hospitak, Mouth to Mask Resuscitator with Filter Child Mask - 00084424900604 Catalog Number : 1056-E

Device Description : Hospitak, Mouth to Mask Resuscitator with Filter Child Mask

Device Class :

Duns Number: 030271837

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

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