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

[?]

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.	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 [?]
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

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0c1b4879-31bd-43b9-b6a7-728cfce833ad
Public Version Date: July 31, 2023
Public Version Number: 7
DI Record Publish Date: September 24, 2015