BAXTER HEALTHCARE CORPORATION

Address:911 NORTH DAVIS,CLEVELAND,MS,38732,US

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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, peritoneal, automatic delivery (FKX) (2) Bandage, liquid (KMF) (1) Dialyzer, high permeability with or without sealed dialysate system (KDI) (1) Set, tubing, blood, with and without anti-regurgitation valve (FJK) (1)

Premarket Exempt

No Yes

Clear

BLOOD CIRCUIT SET - 07332414004095 Catalog Number : 101739

Device Description : SINGLE NEEDLE EXPANSION CHAMBER

Device Class : 2

Duns Number: 005083209

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

TipStop - 07332414113858 Catalog Number : 114555

Device Description : TipStop is a compressive dressing made of a polyamide compressive element covere TipStop is a compressive dressing made of a polyamide compressive element covered with alginate, placed on adhesive film. TipStop has been specially designed to stop bleeding after venipuncture. TipStop is sterilised by irradiation. This product is not made with natural rubber latex.

Device Class : 1

Duns Number: 005083209

Premarket Exempt : No

Product Code : KMF

Prescription Use : No

Device Count : 1

therMaxTherMax Blood Warmer - 07332414123932 Catalog Number : 955516

Device Description : The Blood Warmer Disposable is a disposable circuit for use with the TherMax blo The Blood Warmer Disposable is a disposable circuit for use with the TherMax blood warmer in combination with other PrisMax disposable sets.

Device Class : 2

Duns Number: 005083209

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Sharesource - 15413765545723 Catalog Number : 5CGM01

Device Description : Sharesource is a web-based connectivity platform that allows authorized users, i Sharesource is a web-based connectivity platform that allows authorized users, including nephrologists, clinicians, and nurses in the dialysis center, to remotely view and manage treatment information sent from the Claria APD System.

Device Class : 2

Duns Number: 005083209

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

Sharesource - 25413765545720 Catalog Number : 5CGM01

Device Class : 2

Duns Number: 005083209

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

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