Carefusion Finland 320 Oy

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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

Electrode, electrocardiograph (DRX) (8) INCUBATOR, NEONATAL (FMZ) (2)

Premarket Exempt

No Yes

Clear

N/A - 70885403252572 Catalog Number : 2009110-050R

Device Description : ECG Electrodes, 43mm Round, Foam, Radiolucent, Hydrogel

Device Class :

Duns Number: 367919120

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 50

N/A - 70885403252589 Catalog Number : 2009110-050W

Device Description : ECG Electrodes, 55mm Round, Foam, Wet Gel

Device Class :

Duns Number: 367919120

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 50

N/A - 70885403252596 Catalog Number : 2009110-150

Device Description : ECG Electrodes, 43mm Round, Foam, Hydrogel

Device Class :

Duns Number: 367919120

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 50

N/A - 70885403252602 Catalog Number : 2009111-050

Device Description : ECG Electrodes, 55mm Round, Cloth, Hydrogel

Device Class :

Duns Number: 367919120

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 50

SilverTRACE - 70885403252756 Catalog Number : 2014768-001

Device Description : SilverTRACE™ ECG Electrodes, 35x41mm Oval, Foam, Solid Gel

Device Class :

Duns Number: 367919120

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

SilverTRACE - 70885403252763 Catalog Number : 2014777-001

Device Description : SilverTRACE™ ECG Electrodes, 55mm Round, Foam, Wet Gel

Device Class :

Duns Number: 367919120

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

SilverTRACE - 70885403252770 Catalog Number : 2014782-001

Device Description : SilverTRACE™ ECG Electrodes, 40mm Round, Cloth, Solid Gel

Device Class :

Duns Number: 367919120

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

SilverTRACE - 70885403252787 Catalog Number : 2014783-001

Device Description : SilverTRACE™ ECG Electrodes, 50mm Round, Vinyl Tape, Solid Gel

Device Class :

Duns Number: 367919120

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

AirLife - 70885403252916 Catalog Number : 6600-0270-200

Device Description : Pad Covers for Biliblanket® Phototherapy System, Disposable

Device Class :

Duns Number: 367919120

Premarket Exempt : No

Product Code : FMZ

Prescription Use : Yes

Device Count : 10

AirLife - 70885403252923 Catalog Number : 6600-0461-200

Device Description : Vests for Biliblanket® Phototherapy System, Disposable

Device Class :

Duns Number: 367919120

Premarket Exempt : No

Product Code : FMZ

Prescription Use : Yes

Device Count : 5

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