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) (4) Mouthpiece, Breathing (BYP) (3) Calibrator, Volume, Gas (BXW) (2) Clip, Nose (BXJ) (1)

Premarket Exempt

No Yes

Clear

Breathbite Mouthpiece, Disposable , Tongue Depressing - 00817081027037 Catalog Number : 164950

Device Description : Mouthpiece, Disposable , White, Thermoplastic, Tongue Depressing, Breathbite

Device Class : 1

Duns Number: 020275145

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : Yes

Device Count : 1

SYRINGE, CALIBRATION, ADJ. VOL., ALUMINUM, - 00817081027051 Catalog Number : 192803

Device Description : SYRINGE, CALIBRATION, ADJ. VOL., ALUMINUM,WITH MODIFIED FRONT CAP & 1138 ADAPTER

Device Class : 1

Duns Number: 020275145

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

PFT Kit B, 33mm OD Kit - 00817081027068 Catalog Number : 183114

Device Description : PFT Kit B, 33mm OD Kit with Blue Rubber Nose Clip

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Pulmonary Sample Kit, Disposable Rubber Mouthpiece - 00817081027082 Catalog Number : 180049

Device Description : Pulmonary Sample Kit, Disposable Rubber Mouthpiece

Device Class : 1

Duns Number: 020275145

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : Yes

Device Count : 1

3 Liter Aluminum Calibration Syringe - 00817081027105 Catalog Number : 192717

Device Description : 3 Liter Aluminum Calibration Syringe

Device Class : 1

Duns Number: 020275145

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

PFT Kit E, VBMax36E, with Blue Rubber Nose Clip - 00817081027112 Catalog Number : 189116

Device Description : PFT Kit E, VBMax36E, with Blue Rubber Nose Clip

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Kit, MIR Disposable Turbine & VBMax30E - 00817081027136 Catalog Number : 180058

Device Description : Kit, MIR Disposable Turbine & VBMax30E

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

PFT Kit I, Disposable, VBMax31S, W/ Blue Rubber Nose Clips - 00817081027150 Catalog Number : 187111

Device Description : PFT Kit I, Disposable, VBMax31S, W/ Blue Rubber Nose Clips

Device Class : 2

Duns Number: 020275145

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Noseclip, Disposable , White, Foam Pad - 00817081027174 Catalog Number : 166525

Device Description : Noseclip, Disposable , White, Foam Pad, ndd OEM

Device Class : 1

Duns Number: 020275145

Premarket Exempt : Yes

Product Code : BXJ

Prescription Use : No

Device Count : 1

Breathebite Mouthpiece - 00817081027198 Catalog Number : 164951

Device Description : Breathebite Disposable Mouthpiece

Device Class : 1

Duns Number: 020275145

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : Yes

Device Count : 1

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