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) Incubator, Neonatal (FMZ) (3) Warmer, Infant Radiant (FMT) (2)

Premarket Exempt

No Yes

Clear

AirLife™ - 10190752106116 Catalog Number : 6600-0196-700

Device Description : Infant Skin Temperature Probe, Single Patient Use (Lullaby™, Care Plus™)

Device Class :

Duns Number: 368457563

Premarket Exempt : No

Product Code : FMT

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752106123 Catalog Number : 6600-0208-700

Device Description : Infant Skin Temperature Probe, Single Patient Use (Lullaby™, Care Plus™)

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : FMT

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752106130 Catalog Number : 2074817-001

Device Description : Infant Skin Temperature Probe, Single Patient Use (Giraffe™, Panda™)

Device Class :

Duns Number: 368457563

Premarket Exempt : No

Product Code : FMZ

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752106147 Catalog Number : 2074816-001

Device Description : Infant Skin Temperature Probe, Single Patient Use (Giraffe™, Panda™)

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : FMZ

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752106161 Catalog Number : 2075796-001

Device Description : Infant Skin Temperature Probe, Reusable (Giraffe™, Panda™)

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : FMZ

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752106451 Catalog Number : 403751-023

Device Description : ECG Leadwire, Radiolucent 5-lead, Grabber, AHA, 150 cm/59 in

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752106468 Catalog Number : 403751-024

Device Description : ECG Leadwire, Radiolucent 12-lead, Grabber, AHA, 150 cm/59 in

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

N/A - 10190752106529 Catalog Number : 403751-009

Device Description : ECG Leadwire, DIN, Radiolucent 5-lead, Grabber, AHA, 150 cm/59 in

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752106536 Catalog Number : 411200-001

Device Description : ECG Leadwire Replaceable Set, 5-lead, Snap, AHA, 74cm / 29in

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Multi-Link™ - 10190752106543 Catalog Number : 411200-002

Device Description : ECG Leadwire Replaceable Set, 5-lead, Snap, AHA, 130cm / 51in

Device Class : 2

Duns Number: 368457563

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

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