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

Spirometer, Diagnostic (BZG) (8) Filter, Bacterial, Breathing-Circuit (CAH) (2)

Premarket Exempt

No Yes

Clear

Pulmoguard - B279293202K025 Catalog Number : 29-3202K-025

Device Description : Pulmonary Function Test Filter

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 25

Pulmoguard - B279293202K300 Catalog Number : 29-3202K-300

Device Description : Pulmonary Function Test Filter

Device Class :

Duns Number: 037690120

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 300

Astra Spirometer - B279295100D1 Catalog Number : 29-5100D

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295100L1 Catalog Number : 29-5100L

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295100S1 Catalog Number : 29-5100S

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295102S050 Catalog Number : 29-5102S-050

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295102S1 Catalog Number : 29-5102S

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295201P050 Catalog Number : 29-5201P-050

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295202S050 Catalog Number : 29-5202S-050

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

Astra Spirometer - B279295202S1 Catalog Number : 29-5202S

Device Description : Spirometer

Device Class : 2

Duns Number: 037690120

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

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