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, electrocardiograph (DRX) (9) ELECTRODE, CUTANEOUS (GXY) (1)

Premarket Exempt

No Yes

Clear

Neuroline CupNeurology Surface Electrodes - 05707480021628 Catalog Number : 72610-M/10

Device Description : Cup Electrodes M Connector Lead Wire Length: 100 cm (40")

Device Class :

Duns Number: 305682023

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 10

BlueSensor BRECG Electrodes - 05707480021666 Catalog Number : BR-50-A/12

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

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 12

BlueSensor BRSECG Electrodes - 05707480021680 Catalog Number : BRS-50-A/12

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

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 12

BlueSensor LECG Electrodes - 05707480022069 Catalog Number : L-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 MECG Electrodes - 05707480022076 Catalog Number : M-00-S/50

Device Description : ECG Electrodes Wet Gel Stud Connector

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 50

BlueSensor NECG Electrodes - 05707480022090 Catalog Number : N-00-A/25

Device Description : ECG Electrodes Wet Gel A Fitting

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 25

BlueSensor NECG Electrodes - 05707480022106 Catalog Number : N-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 NECG Electrodes - 05707480022113 Catalog Number : N-10-A/25

Device Description : ECG Electrodes Wet Gel A Connector 10 cm Lead Wire

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 25

BlueSensor NECG Electrodes - 05707480022120 Catalog Number : N-50-K/25

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

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 25

BlueSensor NFECG Electrodes - 05707480022137 Catalog Number : NF-00-S/12

Device Description : ECG Electrodes Solid Gel Stud Connector

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 12

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