Ambu A/S

Address:Baltorpbakken 13,Ballerup Hovedstaden,DK

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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 Ambu White Sensor 4440M Electrod with wet gel and cloth backing. With center snap and PVC free. Radiolucent and MR Conditional. Packaging: 30 pouch/300 inner box/ 3000 carton

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 Ambu White Sensor 4500M Electrode with wet gel and foam backing Center snap and PVC free. For short-term monitoring Packing: 30 pouch/300 inner box/ 3000 carton

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 Ambu White Sensor 4500M-H Electrode with wet gel and foam backing Center snap and PVC free. For short-term monitoring Packing: 60 pouch/300 inner box/ 3000 carton

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 Ambu White Sensor 4535M Electrode with wet gel and foam backing. Center snap and PVC free For short-term monitoring Packing: 60 pouch/300 inner box/ 3000 carton

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 Ambu White Sensor 4560M Electrod with wet gel and foam backing. With center snap and PVC free. Packaging: 60 pouch/300 inner box/ 3000 carton

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 Ambu White Sensor 4570M Electrode with wet gel and foam backing Center snap and PVC free. For short-term monitoring pediatric. Packing: 30 pouch/300 inner box/ 3000 carton

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 Ambu White Sensor 0715M Electrod with solid gel and polymer backing and tab connector. Radiolucent and MR Conditional. Packaging: 100 pouch/ 500 inner box/ 5000 carton

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 Ambu White Sensor 0615M Electrod with solid gel and polymer backing and center tab connector. Radiolucent and MR Conditional. Packaging: 100 pouch/ 500 inner box/ 5000 carton

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 Ambu White Sensor 0215M Electrod with solid gel and polymer backing and tab connector. Radiolucent and MR Conditional. Packaging: 100 pouch/500 inner box/ 5000 carton

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 Ambu White Sensor 0315M Electrod with solid gel and polymer backing and tab connector. Radiolucent and MR Conditional. Packaging: 100 pouch/500 inner box/ 5000 carton

Device Class :

Duns Number: 305682023

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 100

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