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) (6) Tubing, Pressure And Accessories (BYX) (3) Mouthpiece, Breathing (BYP) (1)

Premarket Exempt

No Yes

Clear

PFT Kit F, Disposable, VBMax28E - 00817081027211 Catalog Number : 189188

Device Description : PFT Kit F, Disposable, VBMax28E, with White Foam Nose Clip

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Adapter, Syringe to NDD Syringe Adapter 5030-2 - 00817081027235 Catalog Number : 115614

Device Description : Adapter, Syringe to NDD Syringe Adapter 5030-2

Device Class : 1

Duns Number: 020275145

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

PFT Kit B, Disposable VBMax35 - 00817081027259 Catalog Number : 180117

Device Description : Pulmonary Function Kit B, Disposable, VBMax35, with White Foam Nose Clip and Ell Pulmonary Function Kit B, Disposable, VBMax35, with White Foam Nose Clip and Ellipse Mouthpiece

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

ViroMax - 00817081027273 Catalog Number : 156219

Device Description : Filter, Disposable,Viral/ Bacterial - ViroMax

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

PFT Kit F, VBMax 36E - 00817081027297 Catalog Number : 189196

Device Description : Pulmonary Function Test Kit F, Disposable, VBMax36E, W/ Blue Foam Noseclip

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Pulmonary Function Test Kit B, VBMax 48 MM - 00817081027310 Catalog Number : 188414

Device Description : Pulmonary Function Test Kit B, Disposable, VBMax 48 MM, with Blue Foam Nose Clip

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

PFT KIT A, DISPOSABLE, QTY 100, 31 MM O.D. - 00817081027334 Catalog Number : 182101

Device Description : Pulmonary FunctionKit A, DISPOSABLE, QTY 100, 31 MM O.D.

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Adapter, NDD Syringe Adapter 5030-2 - 00817081027358 Catalog Number : 115616

Device Description : Adapter, NDD Syringe Adapter 5030-2

Device Class : 1

Duns Number: 020275145

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

Adapter, NDD Syringe Adapter 2030-3 - 00817081027372 Catalog Number : 115617

Device Description : Adapter, NDD Syringe Adapter 2030-3

Device Class : 1

Duns Number: 020275145

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

Disposable Cardboard Mouthpiece - 10817081021346 Catalog Number : 162608

Device Description : MOUTHPIECE, DISPOSABLE CARDBOARD, 1-3/16" OD,2.625" L - Case 2400

Device Class :

Duns Number: 020275145

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : Yes

Device Count : 100

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