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) (5) Bedding, Disposable, Medical (KME) (2) Thermometer, Electronic, Clinical (FLL) (2) Electrode, electrocardiograph (DRX) (1)

Premarket Exempt

No Yes

Clear

Multi-Link™ - 10190752184275 Catalog Number : 2090600-212

Device Description : X2 ECG Reusable Trunk Cable, 3-lead for Mindray V12/V21, AHA, 360 cm/12 ft

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752184282 Catalog Number : 2090600-221

Device Description : X2 ECG Reusable Trunk Cable, 3-lead for Mindray Datascope, AHA, 23 cm/9 in

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752184299 Catalog Number : 2090600-222

Device Description : X2 ECG Reusable Trunk Cable, 3-lead for Mindray Datascope, AHA, 270 cm/9 ft

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752184305 Catalog Number : 2090601-240

Device Description : X2 ECG Reusable Telemetry Adapter, 3-lead for Mindray TD60

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752187634 Catalog Number : 2090601-013

Device Description : X2 ECG Reusable Adapter, 12-Lead for GE CARESCAPE ONE

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752188051 Catalog Number : M1024247

Device Description : Reusable Temperature Probes, 400-Series, General Purpose Probe, Adult, 3 m/10 ft.

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : FLL

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752188068 Catalog Number : M1024251

Device Description : Reusable Temperature Probes, 400-Series, General Purpose Probe, Pediatric, 3 m/10 ft.

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : FLL

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752188181 Catalog Number : 2464AAO-20

Device Description : Vital Signs™ Leg Attachment Pad

Device Class : 2

Duns Number: 368457563

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

AirLife™ - 70190752111778 Catalog Number : 6600-0270-200

Device Description : Pad Covers Biliblanket® Phototherapy System, Disposable

Device Class :

Duns Number: 368457563

Premarket Exempt : Yes

Product Code : KME

Prescription Use : Yes

Device Count : 10

AirLife™ - 70190752111785 Catalog Number : 6600-0461-200

Device Description : Vests for Biliblanket® Phototherapy System, Disposable

Device Class :

Duns Number: 368457563

Premarket Exempt : Yes

Product Code : KME

Prescription Use : Yes

Device Count : 5

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