Vyaire Medical Oy

Address:Kuortaneenkatu 2,Helsinki Uusimaa,FI

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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

Vital Signs™ - 10190752109070 Catalog Number :

Device Description : Breathing Circuit, Adult, Expandable, Disposable, 3.0m/120 in With Unifilter Jun Breathing Circuit, Adult, Expandable, Disposable, 3.0m/120 in With Unifilter Junior, Gas Sampling Elbow, Gas Sampling Line(3 m/10 ft.) and Manual Bag, 3 L

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109087 Catalog Number :

Device Description : Co-axial Breathing Circuit, Adult, Disposable, 1.8m/72 in With Elbow, Manual Bag Co-axial Breathing Circuit, Adult, Disposable, 1.8m/72 in With Elbow, Manual Bag, 3 L, HMEF 750/S and Gas Sampling Line, 3.0 m

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109117 Catalog Number :

Device Description : Breathing Circuit, Expandable, Adult, Disposable, 3.0m/120 in With HMEF 750/S, G Breathing Circuit, Expandable, Adult, Disposable, 3.0m/120 in With HMEF 750/S, Gas Sampling Elbow, Manual Bag, 3 L and GasSampling Line, 3 m

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109162 Catalog Number :

Device Description : Breathing Circuit, Expandable, Adult, Disposable, 3.0 m/120 in With Gas Sampling Breathing Circuit, Expandable, Adult, Disposable, 3.0 m/120 in With Gas Sampling Elbow, Manual Bag, 3 L, HMEF 1000 and Gas Sampling Line, 3.0 m

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109179 Catalog Number :

Device Description : Co-axial Breathing Circuit, Adult, Disposable, 1.8 m/72 in With Gas Sampling Elb Co-axial Breathing Circuit, Adult, Disposable, 1.8 m/72 in With Gas Sampling Elbow, HMEF 750/S, Manual Bag, 3L, Gas Sampling Line, 3.0 m and Size 6 Mask With Hook Ring

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109186 Catalog Number :

Device Description : Co-axial Breathing Circuit, Adult, Disposable, 1.5 m/60 in With Gas Sampling Elb Co-axial Breathing Circuit, Adult, Disposable, 1.5 m/60 in With Gas Sampling Elbow, HMEF 750, Manual Bag, 3 L and Gas Sampling Line, 3.0 m

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109193 Catalog Number :

Device Description : Co-axial Circuit, Adult, Disposable 1.5 m/60 in With Gas Sampling Elbow, HMEF 75 Co-axial Circuit, Adult, Disposable 1.5 m/60 in With Gas Sampling Elbow, HMEF 750/S and Manual Bag, 3L

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109209 Catalog Number :

Device Description : Patient Circuit, Expandable, Pediatric, Disposable, 3.0 m/120 in With Gas Sampli Patient Circuit, Expandable, Pediatric, Disposable, 3.0 m/120 in With Gas Sampling Elbow, Uni-Filter Junior and Manual Bag, 2 L

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109216 Catalog Number :

Device Description : Breathing Circuit Components, HMEF 750/S with Elbow, Disposable

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109230 Catalog Number :

Device Description : Breathing Circuit Components, HMEF Mini/s with Elbow, Disposable

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

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