A-M SYSTEMS, LLC

Address:131 BUSINESS PARK LOOP,Sequim,WA,98382,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

Filter, Bacterial, Breathing-Circuit (CAH) (9) Mouthpiece, Breathing (BYP) (1)

Premarket Exempt

No Yes

Clear

VBMax - 00817081020625 Catalog Number : 156511

Device Description : VBMax35, Disposable Pulmonary Function Testing Filter

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

VBMax - 00817081020649 Catalog Number : 156304

Device Description : VBMax30, Disposable Pulmonary Function Testing Filter

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

VBMax - 00817081020663 Catalog Number : 156504

Device Description : VBMax35 Pulmonary Function Testing Filter

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

VBMax - 00817081020687 Catalog Number : 136607

Device Description : VBMax36S, Disposable Pulmonary Function Testing Filter - GraceMed

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

VBMax - 00817081020700 Catalog Number : 146607

Device Description : VBMax36E, Disposable Pulmonary Function Testing Filter - GraceMed

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

VBMax - 00817081020724 Catalog Number : 146507

Device Description : VBMax35E, Disposable Pulmonary Function Testing Filter - GraceMed

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

VBMax - 00817081020748 Catalog Number : 136507

Device Description : VBMax35S, Disposable Pulmonary Function Testing Filter - GraceMed

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

VBMax - 00817081020762 Catalog Number : 146907

Device Description : VBMax28E, Disposable Pulmonary Function Testing Filter - GraceMed

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

VBMax - 00817081020786 Catalog Number : 136907

Device Description : VBMax28S, Disposable Pulmonary Function Testing Filter - GraceMed

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Disposable Thermoplastic Mouthpiece - 00817081020809 Catalog Number : 164907

Device Description : Disposable Thermoplastic Mouthpiece

Device Class : 1

Duns Number: 020275145

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : Yes

Device Count : 1

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