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

Pump, infusion, elastomeric (MEB) (10)

Premarket Exempt

No Yes

Clear

Ambu® ACTion™ Fuser Pump - 05707480155941 Catalog Number : 418108200C

Device Description : Action Fuser, 200 mL, 1-6 mL/hr Reg, Dual Cath, Splitter

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

Ambu® ACTion™ Fuser Pump - 05707480155965 Catalog Number : 418104650C

Device Description : Action Fuser, 650 mL, 5-15 mL/hr Reg, 140 mm Cath, 6" Intro

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

Ambu® ACTion™ Fuser Pump - 05707480155989 Catalog Number : 418103200C

Device Description : Action Fuser, 200 mL, 1-6 mL/hr Reg, 140 mm Cath, 6" intro

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

Ambu® ACTion™ Fuser Pump - 05707480156009 Catalog Number : 418108400C

Device Description : Action Fuser, 400 mL, 1-6 mL/hr Reg, Dual Cath, Splitter

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

Ambu® ACTion™ Fuser Pump - 05707480156023 Catalog Number : 418106400C

Device Description : ACTion Fuser 400 ml, 5-15 ml/hr, Dual Cath 190 mm, Splitter

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

Ambu® ACTion™ Fuser Pump - 05707480156047 Catalog Number : 418113400C

Device Description : ACTion Fuser,400 mL,1-6 ml, Dual 190mm Cath,9"Intro, Spliter

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

Ambu® ACTion™ Fuser Pump - 05707480156061 Catalog Number : 418103400M

Device Description : Action Fuser, 400 mL, 1-6 mL/hr Reg, 140 mm Cath, 6" Intro

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

Ambu® ACTion™ Fuser Pump - 05707480156085 Catalog Number : 418108200M

Device Description : Action Fuser, 200 mL, 1-6 mL/hr Reg, Dual Cath, Splitter

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

Ambu® ACTion™ Fuser Pump - 05707480156108 Catalog Number : 418104650M

Device Description : Action Fuser, 650 mL, 5-15 mL/hr Reg, 140 mm Cath, 6" Intro

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

Ambu® ACTion™ Fuser Pump - 05707480156122 Catalog Number : 418103200M

Device Description : Action Fuser, 200 mL, 1-6 mL/hr Reg, 140 mm Cath, 6" intro

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : MEB

Prescription Use : Yes

Device Count : 1

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