Ambu A/S

Address:Baltorpbakken 13,Ballerup Hovedstaden,DK

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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, CUTANEOUS (GXY) (6) Electrode, electrocardiograph (DRX) (4)

Premarket Exempt

No Yes

Clear

BlueSensor VLECG Electrodes - 05707480022250 Catalog Number : VL-00-S/25

Device Description : ECG Electrodes Wet Gel Stud Connector

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 25

BlueSensor VLECG Electrodes - 05707480022267 Catalog Number : VL-50-A/25

Device Description : ECG Electrodes Wet Gel A Connector 50 cm Lead Wire

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 25

BlueSensor VLCECG Electrodes - 05707480022274 Catalog Number : VLC-00-S/10

Device Description : ECG Electrodes Wet Gel Stud Connector

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 10

BlueSensor BRECG Electrodes - 05707480022335 Catalog Number : BR-80-K/12

Device Description : ECG Electrodes Solid Gel K Connector 80 cm Lead Wire

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 12

Neuroline 700Neurology Surface Electrodes - 05707480022526 Catalog Number : 70002-K/12

Device Description : Solid Gel Electrodes K Connector Lead Wire Length: 20 cm (8")

Device Class :

Duns Number: 305682023

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 12

Neuroline 700Neurology Surface Electrodes - 05707480022540 Catalog Number : 70005-K/12

Device Description : Solid Gel Electrodes K Connector Lead Wire Length: 50 cm (20")

Device Class :

Duns Number: 305682023

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 12

Neuroline 700Neurology Surface Electrodes - 05707480022564 Catalog Number : 70010-J/12

Device Description : Solid Gel Electrodes J Connector Lead Wire Length: 100 cm (40")

Device Class :

Duns Number: 305682023

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 12

Neuroline 700Neurology Surface Electrodes - 05707480022571 Catalog Number : 70010-K/12

Device Description : Solid Gel Electrodes K Connector Lead Wire Length: 100 cm (40")

Device Class :

Duns Number: 305682023

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 12

Neuroline 700Neurology Surface Electrodes - 05707480022595 Catalog Number : 70015-K/12

Device Description : Solid Gel Electrodes K Connector Lead Wire Length: 150 cm (60")

Device Class :

Duns Number: 305682023

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 12

Neuroline 710Neurology Surface Electrodes - 05707480022618 Catalog Number : 71005-K/12

Device Description : Solid Gel Electrodes K Connector Lead Wire Length: 50 cm (20")

Device Class :

Duns Number: 305682023

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 12

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