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) (5) Cable, Transducer And Electrode, Patient, (Including Connector) (DSA) (3) BAG, RESERVOIR (BTC) (2)

Premarket Exempt

No Yes

Clear

Multi-Link™ - 10190752106970 Catalog Number : 421932-001

Device Description : ECG Leadwire 6-lead, Grabber, AHA, 74 cm/29 in

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752106987 Catalog Number : 421932-002

Device Description : ECG Leadwire 6-lead, Grabber, AHA, 130 cm/51 in

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752106994 Catalog Number : 421932-003

Device Description : ECG Leadwire 6-lead, Grabber, AHA, 74 cm/29 in & 130 cm/51 in

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752108936 Catalog Number : M1036386

Device Description : Breathing Bag, Disposable, 1 L

Device Class : 1

Duns Number: 368457563

Premarket Exempt : Yes

Product Code : BTC

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752108943 Catalog Number : M1036387

Device Description : Breathing Bag, Disposable, 2L

Device Class : 1

Duns Number: 368457563

Premarket Exempt : Yes

Product Code : BTC

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752108981 Catalog Number :

Device Description : Breathing Circuit, Expandable, Adult, Disposable, 3.0 m/120 in With HMEF1000, Ga Breathing Circuit, Expandable, Adult, Disposable, 3.0 m/120 in With HMEF1000, Gas Sampling Elbow, Gas Sampling line, 3.0m 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™ - 10190752108998 Catalog Number :

Device Description : Breathing Circuit, Expandable, Pediatric, Disposable, 1.8 m/72 in With Gas Sampl Breathing Circuit, Expandable, Pediatric, Disposable, 1.8 m/72 in With Gas Sampling Elbow, Gas Sampling Line (3m/10ft.), Manual Bag, 1 L and HMEF Mini

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109001 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, 3L and HMEF 1000 (x2)

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109049 Catalog Number :

Device Description : Breathing Circuit, Expandable, Adult, Disposable, 2.4 m/96 in With HMEF 750/S, G Breathing Circuit, Expandable, Adult, Disposable, 2.4 m/96 in With HMEF 750/S, Gas Sampling Elbow, Manual Bag, 3L, Size 6 Mask with Hook Ring and Gas Sampling Line, 3m

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109056 Catalog Number :

Device Description : Breathing Circuit, Expandable, Adult, Disposable, 3 m/120 in With HMEF 750/s, Ga Breathing Circuit, Expandable, Adult, Disposable, 3 m/120 in With HMEF 750/s, Gas Sampling Elbow, Manual Bag, 3 L, Size 6 Mask with Hook Ring and Gas Sampling Line, 3 m

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

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