FDA.reportPublic FDA data

PrismaSATE

Primary DI
07332414108571
Brand
PrismaSATE
Company
BAXTER INTERNATIONAL INC.
Model
113914
Catalog number
113914
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.
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPODIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37332414108572PackageGS12In Commercial Distribution
07332414108571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3733241410857237332414108572
07332414108571073324141085717332414108571

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis dialysate solutionA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius0
Storage Environment Temperature39 Degrees Fahrenheit0

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
005146311
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412000985Arthromatic/Uromatic2C40062C40062016-09-24
00085412001005Arthromatic/Uromatic2C40142C40142016-09-24
00085412014869Baxter1C86141C86142016-09-24
00085412000978Arthromatic/Uromatic2C40052C40052016-09-24
00085412001050Arthromatic/Uromatic2C40402C40402016-09-24
00085412001067Arthromatic/Uromatic2C40412C40412016-09-24
00085412004136Baxter2C76272C76272016-09-24
00085412027388VIAL-MATE2B80712B80712016-09-24
00085412031859Baxter1C86271C86272016-09-24
00085412088303V-LINK/VITALSHIELD6N83996N83992016-09-24
00085412091785ONE-LINK7N83997N83992016-09-24
00085412087672LOW RECIRCULATION VOLUME APD SETN5C8305CN5C8305C2015-09-24
00085412088433AUTOMATED PD SETR5C4479CR5C4479C2015-09-24
00085412090078INTERGRATED APD SETL5C4531L5C45312015-09-24
00085412007021HomeChoice APD System5C44715C44712015-10-23
00085412007038HomeChoice APD System5C4471R5C4471R2015-10-23
00085412026350HomeChoice PRO APD System5C8310R5C8310R2015-10-23
00085412079165HomeChoice PRO APD System5C83105C83102015-10-23
00085412088341V-LINK/VITALSHIELD6N83786N83782016-09-24
00085412088327V-LINK/VITALSHIELD6N83746N83742016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10857940006671Hemo-DialEDLAW PHARMACEUTICALS, INC.KPO2022-02-24
10857940006688Hemo-DialEDLAW PHARMACEUTICALS, INC.KPO2022-02-24
38051411600351HMB32HAEMOPHARM BIOFLUIDS SRLKPO2021-07-03
38051411600061HMB32HAEMOPHARM BIOFLUIDS SRLKPO2020-03-11
M535RFP211WW0NxStage PureFlow SolutionNXSTAGE MEDICAL, INC.KPO2018-10-01
10857940006664HEMO-DIALEDLAW PHARMACEUTICALS, INC.KPO2017-12-22
10857940006657Hemo-DialEDLAW PHARMACEUTICALS, INC.KPO2017-10-06
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