BAXTER INTERNATIONAL INC.

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- Catalog Number : MSGDHC1325A

Device Description : The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH cathete The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies for insertion of the catheter.

Device Class : 2

Duns Number: 005146311

Premarket Exempt : Yes

Product Code : PEV

Prescription Use : Yes

Device Count : 1

Device Description : Sharesourece is a web-based connectivity platform that allows authorized users, Sharesourece 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 Amia APD System.

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

- Catalog Number : 105353S

Device Description : The product is a sterile dialysis solution intended for treatment of acute kidne The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

- Catalog Number : 105351S

Device Description : The product is a sterile dialysis solution intended for treatment of acute kidne The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

- Catalog Number : 106957S

Device Description : The product is a sterile dialysis solution intended for treatment of acute kidne The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

- Catalog Number : 107501S

Device Description : The product is a sterile dialysis solution intended for treatment of acute kidne The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

- Catalog Number : 107580S

Device Description : The product is a sterile dialysis solution intended for treatment of acute kidne The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

- Catalog Number : 110411S

Device Description : The product is a sterile dialysis solution intended for treatment of acute kidne The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

- Catalog Number : 113914

Device Description : The product is a sterile dialysis solution intended for treatment of acute kidne The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

- Catalog Number : 113915

Device Description : The product is a sterile dialysis solution intended for treatment of acute kidne The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.

Device Class : 2

Duns Number: 005146311

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1