AccessGUDID - DEVICE: PRISMASATE (07332414114763)

GUDID

Device Identifier (DI) Information

Brand Name: PRISMASATE
Version or Model: 114723
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 114723
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 07332414114763
Issuing Agency: GS1
Commercial Distribution End Date: May 08, 2019
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):	Yes
Device labeled as "Not made with natural rubber latex":	No
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?
35849	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.	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 [?]
K120333	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d6f8916d-ea88-4c29-9c23-6c885eda3934
Public Version Date: May 14, 2019
Public Version Number: 5
DI Record Publish Date: September 24, 2015