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

Pump, infusion, elastomeric (MEB) (7) Ventilator, emergency, manual (resuscitator) (BTM) (3)

Premarket Exempt

Yes No

Clear

SPUR® Infant Resuscitator - 05707480154555 Catalog Number : 544212051

Device Description : SPUR II Inf Tube Res, Pop, Inf Mask, Mano, PEEP, Exp Filter

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

SPUR® Infant Resuscitator - 05707480154579 Catalog Number : 544212061

Device Description : SPUR II Inf Tube Res, Pop-off, Inf Mask, PEEP, Exp Filter

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

SPUR® Infant Resuscitator - 05707480154593 Catalog Number : 544216051

Device Description : SPUR II Inf Tube, Pop, Neo & Inf Mask, Mano, PEEP, Ex Filter

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ambu® ACTion™ Block Pump - 05707480155606 Catalog Number : 419102650C

Device Description : Action Block, 650 mL, 5-15 mL/hr Regulator

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

Ambu® ACTion™ Block Pump - 05707480155620 Catalog Number : 418202400C

Device Description : Action Block, 400 mL, 5-15 mL/hr Regulator

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

Ambu® ACTion™ Block Pump - 05707480155644 Catalog Number : 419105650C

Device Description : Action Block, 650 mL, 1-6 mL/hr Regulator

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

Ambu® ACTion™ Block Pump - 05707480155668 Catalog Number : 418201200C

Device Description : Action Block, 200 mL, 1-6 mL/hr Regulator

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

Ambu® ACTion™ Block Pump - 05707480155682 Catalog Number : 418201400C

Device Description : Action Block, 400 mL, 1-6 mL/hr Regulator

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

Ambu® ACTion™ Block Pump - 05707480155705 Catalog Number : 418202200C

Device Description : Action Block, 200 mL, 5-15 mL/hr Regulator

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

Ambu® ACTion™ Block Pump - 05707480155729 Catalog Number : 419151650C

Device Description : Action Block, MBII, 650 mL, 5-15 mL/hr Regulator

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

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