Xvivo Perfusion AB

Address:Massans gata 10,Goteborg Vastra Gotaland,SE

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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

System, Perfusion, Kidney (KDN) (3) System/Device, Pharmacy Compounding (NEP) (2) Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs (PHO) (1)

Premarket Exempt

No Yes

Clear

PERFADEX Plus® - 07350069520241 Catalog Number : 19900

Device Description : Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containin Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is intended for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.Package size: 2 x 3000ml

Device Class : 2

Duns Number: 559895730

Premarket Exempt : No

Product Code : KDN

Prescription Use : Yes

Device Count : 1

PERFADEX Plus (Click US) - 07350069520289 Catalog Number : 19850

Device Description : PERFADEX Plus is a pre-buffered, extracellular solution of dextran 40 containing PERFADEX Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.Package size: 10 x 1000ml

Device Class : 2

Duns Number: 559895730

Premarket Exempt : No

Product Code : KDN

Prescription Use : Yes

Device Count : 1

PERFADEX® Plus - 07350069520296 Catalog Number : 19950

Device Class : 2

Duns Number: 559895730

Premarket Exempt : No

Product Code : KDN

Prescription Use : Yes

Device Count : 1

XVIVO Click Adapter - 07350069520302 Catalog Number : 19125

Device Description : Intended as an adapter between the Perfadex® Plus bag and a tubing set with a st Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spike.

Device Class : 2

Duns Number: 559895730

Premarket Exempt : Yes

Product Code : NEP

Prescription Use : Yes

Device Count : 1

XVIVO Click Adapter - 07350069520425 Catalog Number : 19024

Device Description : Intended as an adapter between the Perfadex® Plus bag and a tubing set with a st Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spike.

Device Class : 2

Duns Number: 559895730

Premarket Exempt : Yes

Product Code : NEP

Prescription Use : Yes

Device Count : 1

XVIVO Lung Cannula Set II™ - 07350069520500 Catalog Number : 19023

Device Description : XVIVO Lung Cannula Set II™ is a sterile, single-use set intended to be used to c XVIVO Lung Cannula Set II™ is a sterile, single-use set intended to be used to connect isolated donor lungs to an extracorporeal perfusion system for ex-vivo assessment.

Device Class : 3

Duns Number: 559895730

Premarket Exempt : No

Product Code : PHO

Prescription Use : Yes

Device Count : 1

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