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

Cable, Transducer And Electrode, Patient, (Including Connector) (DSA) (6) Cable, Electrode (IKD) (2) Filter, Bacterial, Breathing-Circuit (CAH) (2)

Premarket Exempt

No Yes

Clear

Vital Signs™ - 10190752109247 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/S, Manual Bag, 3 L and Size 6 Face Mask With Hook Ring

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109278 Catalog Number :

Device Description : Breathing Circuit, Pediatric, Disposable, 3.75 m/150 in With Manual Bag, 1 L, Ga Breathing Circuit, Pediatric, Disposable, 3.75 m/150 in With Manual Bag, 1 L, Gas Sampling Elbow, HMEF 750/S and Gas Sampling Line, 6 m

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109414 Catalog Number : 1590AAO

Device Description : Vital Signs™ Fetal Spiral Electrode Cable for Corometrics™, Round Connector, 2.4 m

Device Class : 2

Duns Number: 368457563

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109421 Catalog Number : 1591AAO

Device Description : Vital Signs™ Fetal Spiral Electrode Cable for Corometrics™, Rectangular Connector, 2.4 m

Device Class : 2

Duns Number: 368457563

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109469 Catalog Number : 22341809V

Device Description : Vital Signs™ Diagnostic Cardiology Care Cable, 12-lead, AHA

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752109483 Catalog Number : 2029893-001V

Device Description : Vital Signs™ Diagnostic Cardiology Cable Leadwire, Banana, AHA, 3.2 m/ 10 ft 6 in

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752109568 Catalog Number :

Device Description : Multi-Link™ Maternal/Fetal ECG Y Adapter Cable for Corometrics™

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752109575 Catalog Number :

Device Description : Multi-Link™ Maternal ECG Cable and 3-Leadwire Set for Corometrics™, AHA, Rectan Multi-Link™ Maternal ECG Cable and 3-Leadwire Set for Corometrics™, AHA, Rectangular Connector, 2.4 m/ 8 ft

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752109599 Catalog Number :

Device Description : Multi-Link™ Maternal ECG Cable and 3-Leadwire Set for Corometrics™, AHA, Round C Multi-Link™ Maternal ECG Cable and 3-Leadwire Set for Corometrics™, AHA, Round Connector, 2.4 m/ 8 ft

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752109971 Catalog Number : 412596-001

Device Description : ECG Leadwire, Individual Replacement, Red LL, Snap, AHA, 74cm/29in

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

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