GAMBRO DASCO SPA

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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

ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS (KOC) (4) Dialyzer, high permeability with or without sealed dialysate system (KDI) (3) SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE (FJK) (2) SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES (MON) (1)

Premarket Exempt

No Yes

Clear

NA - 07332414004699 Catalog Number : 101354

Device Description : S-660-C Accessory Y connector

Device Class : 2

Duns Number: 428788780

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

NA - 07332414010867 Catalog Number : 101593

Device Description : SP-C13 Accessory spike

Device Class : 2

Duns Number: 428788780

Premarket Exempt : No

Product Code : KOC

Prescription Use : Yes

Device Count : 1

NA - 07332414032531 Catalog Number : 102074

Device Description : SP-394 Accessory reinfusion line

Device Class : 2

Duns Number: 428788780

Premarket Exempt : No

Product Code : KOC

Prescription Use : Yes

Device Count : 1

PHOENIX - 07332414042035 Catalog Number : 103453

Device Description : Phoenix is a self-contained, microprocessor-controlled device that provides hemo Phoenix is a self-contained, microprocessor-controlled device that provides hemodialysis, hemofiltration and ultrafiltration therapies.

Device Class : 2

Duns Number: 428788780

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

NA - 07332414044732 Catalog Number : 105551

Device Description : SP-390 Accessory adaptor

Device Class : 2

Duns Number: 428788780

Premarket Exempt : No

Product Code : KOC

Prescription Use : Yes

Device Count : 1

NA - 07332414048914 Catalog Number : 105762

Device Description : GMB-SP127 Accessory Y connector

Device Class : 2

Duns Number: 428788780

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

NA - 07332414075439 Catalog Number : 107620

Device Description : SP-420 Accessory extension line

Device Class : 2

Duns Number: 428788780

Premarket Exempt : No

Product Code : KOC

Prescription Use : Yes

Device Count : 1

NA - 07332414075828 Catalog Number : 107650

Device Description : SP 418 (9L Bag) Accessory Drain Bag

Device Class : 1

Duns Number: 428788780

Premarket Exempt : Yes

Product Code : MON

Prescription Use : Yes

Device Count : 1

EXALIS - 07332414106119 Catalog Number : 6041909

Device Description : Exalis is an integrated product able to acquire, process and supply data require Exalis is an integrated product able to acquire, process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data.

Device Class : 2

Duns Number: 428788780

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

EXALIS - 07332414106126 Catalog Number : 113297

Device Class : 2

Duns Number: 428788780

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

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