DEVICE: PrismaSATE (07332414037048)
Device Identifier (DI) Information
PrismaSATE
105351
In Commercial Distribution
105351S
BAXTER INTERNATIONAL INC.
105351
In Commercial Distribution
105351S
BAXTER INTERNATIONAL INC.
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 Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
61616 | Haemodialysis dialysate solution |
A sterile, ready-to-use solution with an electrolyte composition similar to that of blood (i.e., a dialysate) intended to exchange solutes with blood across a semi-permeable membrane. It is used within a haemodialysis system to remove metabolic wastes from the blood and to help maintain physiological blood electrolyte and pH levels. The product typically includes glucose and salts of the following constituents: sodium, potassium, magnesium, calcium, chloride, and anions of weak acids [e.g., bicarbonate (HCO3-), acetate, citrate, lactate]. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KPO | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: more than 39 Degrees Fahrenheit |
Storage Environment Temperature: more than 4 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
60002b9c-2e5d-42a5-a367-702e99e6b89a
July 31, 2023
7
September 24, 2015
July 31, 2023
7
September 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
37332414037049 | 2 | 07332414037048 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
Medinfo_medproducts@baxter.com