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

No Yes

Clear

Ambu WhiteSensor 4440MECG Electrodes - 05060038510594 Catalog Number : 4440M

Device Description : Ambu White Sensor 4440M Electrod with wet gel and cloth backing. With center sna

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 30

Ambu WhiteSensor 4500MECG Electrodes - 05060038512482 Catalog Number : 4500M

Device Description : Ambu White Sensor 4500M Electrode with wet gel and foam backing Center snap and

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 30

Ambu WhiteSensor 4500M-HECG Electrodes - 05060038512796 Catalog Number : 4500M-H

Device Description : Ambu White Sensor 4500M-H Electrode with wet gel and foam backing Center snap an

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 60

Ambu WhiteSensor 4535MECG Electrodes - 05060038512864 Catalog Number : 4535M

Device Description : Ambu White Sensor 4535M Electrode with wet gel and foam backing. Center snap and

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 60

Ambu WhiteSensor 4560MECG Electrodes - 05060038512994 Catalog Number : 4560M

Device Description : Ambu White Sensor 4560M Electrod with wet gel and foam backing. With center snap

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 60

Ambu WhiteSensor 4570MECG Electrodes - 05060038513120 Catalog Number : 4570M

Device Description : Ambu White Sensor 4570M Electrode with wet gel and foam backing Center snap and

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 30

Ambu WhiteSensor 0715M BIOTABSECG Electrodes - 05060038513632 Catalog Number : 0715M

Device Description : Ambu White Sensor 0715M Electrod with solid gel and polymer backing and tab conn

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 100

Ambu WhiteSensor 0615M BIOTABSECG Electrodes - 05060038514028 Catalog Number : 0615M

Device Description : Ambu White Sensor 0615M Electrod with solid gel and polymer backing and center t

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 100

Ambu WhiteSensor 0215M BIOTABSECG Electrodes - 05060038514424 Catalog Number : 0215M

Device Description : Ambu White Sensor 0215M Electrod with solid gel and polymer backing and tab conn

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 100

Ambu WhiteSensor 0315M BIOTABSECG Electrodes - 05060038514448 Catalog Number : 0315M

Device Description : Ambu White Sensor 0315M Electrod with solid gel and polymer backing and tab conn

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 100

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