AccessGUDID - DEVICE: PrismaSATE (07332414037031)

GUDID

Device Identifier (DI) Information

Brand Name: PrismaSATE
Version or Model: 105353
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 105353S
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 07332414037031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Haemodialysis concentrate	A product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It is intended to remove metabolic waste from the blood 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]. It is supplied as a solution or a dry powder. After application, this device cannot be reused.

GMDN Preferred Term Name

GMDN Definition

Haemodialysis concentrate

A product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It is intended to remove metabolic waste from the blood 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]. It is supplied as a solution or a dry powder. After application, this device cannot be reused.

FDA Product Code

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Product Code	Product Code Name
KPO	DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Temperature: more than 4 Degrees Celsius
Storage Environment Temperature: more than 39 Degrees Fahrenheit

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0c1b4879-31bd-43b9-b6a7-728cfce833ad
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2015