GAMBRO DASCO SPA

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

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

Device Class : 2

Duns Number: 428788780

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

EXALIS - 07332414106126 Catalog Number : 113297

Device Description : Exalis is an integrated product able to acquire, process and supply data require

Device Class : 2

Duns Number: 428788780

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

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