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) (9) ANALYZER, GAS, OXYGEN, GASEOUS-PHASE (CCL) (1)

Premarket Exempt

No Yes

Clear

N/A - 70885403253111 Catalog Number : 2009110-005

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

Device Class :

Duns Number: 367919120

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 5

SilverTRACE - 70885403253197 Catalog Number : 2014779-001

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

Device Class :

Duns Number: 367919120

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

SilverTRACE - 70885403253562 Catalog Number : 2014784-001

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 : 5

SilverTRACE - 70885403253579 Catalog Number : 2014785-001

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 : 7

N/A - 70885403253814 Catalog Number : 2009109-005

Device Description : ECG Electrodes, 55mm Round, Clear Tape, Hydrogel

Device Class :

Duns Number: 367919120

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 3

N/A - 70885403253821 Catalog Number : 2009109-050

Device Description : ECG Electrodes, 55mm Round, Clear Tape, Hydrogel

Device Class :

Duns Number: 367919120

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 50

N/A - 70885403253838 Catalog Number : 2009110-003

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

Device Class :

Duns Number: 367919120

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 3

SilverTRACE - 70885403253845 Catalog Number : 2014776-001

Device Description : SilverTRACE™ ECG Electrodes, 44x32mm Rectangular, Foam, Wet Gel

Device Class :

Duns Number: 367919120

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 10

SilverTRACE - 70885403253852 Catalog Number : 2014778-001

Device Description : SilverTRACE™ ECG Electrodes, 44x28mm Rectangular, Foam, Banana Plug, Wet Gel

Device Class :

Duns Number: 367919120

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

Vital Signs - 70885403255115 Catalog Number : 733188

Device Description : Anesthesia Gas Sampling Line, Disposable, 2 m/7 ft

Device Class :

Duns Number: 367919120

Premarket Exempt : No

Product Code : CCL

Prescription Use : Yes

Device Count : 100

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