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) (4)

Premarket Exempt

No Yes

Clear

SilverTRACE - 70885403255641 Catalog Number : 91920031

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 : 25

Mactrode - 70885403256785 Catalog Number : 2066867-010

Device Description : Mactrode&#8482 Wide Mouth Clips for 12-lead

Device Class :

Duns Number: 367919120

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 10

Mactrode - 70885403258901 Catalog Number : 2066867-014

Device Description : Mactrode&#8482 Wide Mouth Clips for 15-lead

Device Class :

Duns Number: 367919120

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 14

N/A - 70885403287048 Catalog Number : 2009101-404

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

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