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) (10)

Premarket Exempt

Yes No

Clear

BlueSensor NFECG Electrodes - 05707480022144 Catalog Number : NF-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 PECG Electrodes - 05707480022168 Catalog Number : P-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 QECG Electrodes - 05707480022175 Catalog Number : Q-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 QECG Electrodes - 05707480022182 Catalog Number : Q-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 RECG Electrodes - 05707480022199 Catalog Number : R-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 RECG Electrodes - 05707480022205 Catalog Number : R-00-S/25

Device Description : ECG Electrodes with wet Gel and Stud Connector

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 25

BlueSensor SPECG Electrodes - 05707480022212 Catalog Number : SP-00-A/50

Device Description : ECG Electrodes Wet Gel A Fitting

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 50

BlueSensor SPECG Electrodes - 05707480022229 Catalog Number : SP-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 SUECG Electrodes - 05707480022236 Catalog Number : SU-00-A/60

Device Description : ECG Electrodes Wet Gel A Fitting

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 60

BlueSensor SUECG Electrodes - 05707480022243 Catalog Number : SU-00-C/100

Device Description : ECG Electrodes Wet Gel For Clip

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 100

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