S D I DIAGNOSTICS 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

Filter, Bacterial, Breathing-Circuit (CAH) (10)

Premarket Exempt

No Yes

Clear

Pulmoguard - B279293104CK050 Catalog Number : 29-3104CK-050

Device Description : Pulmonary Function Test Filter

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 50

Pulmoguard - B279293104CK100 Catalog Number : 29-3104CK-100

Device Description : Pulmonary Function Test Filter

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 100

Pulmoguard - B279293104K050 Catalog Number : 29-3104K-050

Device Description : Pulmonary Function Test Filter

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 50

Pulmoguard - B279293104K100 Catalog Number : 29-3104K-100

Device Description : Pulmonary Function Test Filter

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 100

Pulmoguard - B279293105C040 Catalog Number : 29-3105C-040

Device Description : Pulmonary Function Test Filter

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 40

Pulmoguard - B279293105C080 Catalog Number : 29-3105C-080

Device Description : Pulmonary Function Test Filter

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 80

Pulmoguard - B279293105CK040 Catalog Number : 29-3105CK-040

Device Description : Pulmonary Function Test Filter

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 40

Pulmoguard - B279293105CK080 Catalog Number : 29-3105CK-080

Device Description : Pulmonary Function Test Filter

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 80

Pulmoguard - B279293105K050 Catalog Number : 29-3105K-050

Device Description : Pulmonary Function Test Filter

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 50

Pulmoguard - B279293105K100 Catalog Number : 29-3105K-100

Device Description : Pulmonary Function Test Filter

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 100

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