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

Ventilator, emergency, manual (resuscitator) (BTM) (10)

Premarket Exempt

Yes No

Clear

SPUR® Adult Resuscitator - 05707480154357 Catalog Number : 524611017

Device Description : Ambu Adult SPUR II Tube Res, Med Mask, Manometer, Exp Filter

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

SPUR® Adult Resuscitator - 05707480154371 Catalog Number : 524611048

Device Description : SPUR II Adult Tube Res, Pop-off, Med Mask, Exp Filter

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

SPUR® Adult Resuscitator - 05707480154395 Catalog Number : 524611051

Device Description : SPUR II Adult Tube Res, Med Mask, Mano, PEEP, Exp Filter

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Single Patient Use Resuscitator - 05707480154418 Catalog Number : 530213017

Device Description : SPUR II Ped Bag Res, Pop-off, Tod Mask, Mano, Exp Filter

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Single Patient Use Resuscitator - 05707480154432 Catalog Number : 530613048

Device Description : SPUR II Ped Bag Res, Pop-off, Tod Mask, Exp Filter

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Single Patient Use Resuscitator - 05707480154456 Catalog Number : 530613061

Device Description : SPUR II Ped Bag Res, Pop-off, Tod Mask, PEEP, Exp Filter

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Single Patient Use Resuscitator - 05707480154470 Catalog Number : 531613051

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

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Single Patient Use Resuscitator - 05707480154494 Catalog Number : 531613061

Device Description : SPUR II Ped Tube Res, Pop-off, Tod 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 - 05707480154517 Catalog Number : 540212061

Device Description : SPUR II Inf Bag 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 - 05707480154531 Catalog Number : 544212048

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

Device Class : 2

Duns Number: 305682023

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

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