PrismaSATE 105353S

GUDID 37332414037032

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.

BAXTER INTERNATIONAL INC.

Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution Haemodialysis dialysate solution
Primary Device ID37332414037032
NIH Device Record Key0c1b4879-31bd-43b9-b6a7-728cfce833ad
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrismaSATE
Version Model Number105353
Catalog Number105353S
Company DUNS005146311
Company NameBAXTER INTERNATIONAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 0
Storage Environment TemperatureBetween 4 Degrees Celsius and 0

Device Identifiers

Device Issuing AgencyDevice ID
GS107332414037031 [Primary]
GS137332414037032 [Package]
Contains: 07332414037031
Package: CASE [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPODIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-04
Device Publish Date2015-09-24

On-Brand Devices [PrismaSATE]

37332414123094The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal
37332414114788The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal
37332414114771The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal
37332414114764The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal
37332414108626The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal
37332414108619The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal
37332414108602The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal
37332414108596The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal
37332414108589The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal
37332414108572The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal
37332414100170The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal
37332414074648The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal
37332414074013The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal
37332414066834The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal
37332414037049The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal
37332414037032The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal

Trademark Results [PrismaSATE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRISMASATE
PRISMASATE
78032988 2670296 Live/Registered
GAMBRO RENAL PRODUCTS, INC.
2000-10-30

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