PrismaSATE - The product is a sterile dialysis solution - BAXTER INTERNATIONAL INC.

Duns Number:005146311

Device Description: The product is a sterile dialysis solution intended for treatment of acute kidney disease 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.

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More Product Details

Catalog Number

105351S

Brand Name

PrismaSATE

Version/Model Number

105351

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KPO

Product Code Name

DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Device Record Status

Public Device Record Key

60002b9c-2e5d-42a5-a367-702e99e6b89a

Public Version Date

October 11, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

37332414037049

Quantity per Package

2

Contains DI Package

07332414037048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"BAXTER INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 358