BiCart

Primary DI
07332414110574
Brand
BiCart
Company
Vantive Health GmbH
Model
1250
Catalog number
114014
Device description
Sodium Bicarbonate for Hemodialysis
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013724000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013724000BICARTGambro Renal Products2002-01-08KPO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37332414110575PackageGS16In Commercial Distribution
07332414110574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3733241411057537332414110575
07332414110574073324141105747332414110574

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis concentrateA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight1250Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius
Storage Environment Temperature0104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)553-6898Us.RENAL.Support.Co@vantive.com

Regulatory Flags#

DUNS number
480723888
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332414200183RevaclearRevaclear 500955543A2026-05-29
07332414201340PRISMAFLEX SET M100106697MDR106697MDR2026-03-27
07332414201364PRISMAFLEX SET M150109990MDR109990MDR2026-03-27
07332414201388PRISMAFLEX SET M60106696MDR106696MDR2026-03-27
07332414088316BiCart7201097332015-09-24
07332414127213CLCA - CLEANCART A9558509558502023-12-01
07332414127220CLCC - CLEANCART C9558519558512023-12-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10857940006626Hemo-DialEDLAW PHARMACEUTICALS, INC.KPO2017-03-15
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