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510(k) Data Aggregation
K Number
K072760Device Name
SOLCART B
Manufacturer
B. BRAUN MEDIZINTECHNOLOGIE GMBH
Date Cleared
2008-01-29
(123 days)
Product Code
KPO
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
B. BRAUN MEDIZINTECHNOLOGIE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Solcart B is intended for use in bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.
Device Description
Solcart B consists of a powder concentrate used to prepare bicarbonate concentrate solution for use in hemodialysis. Solcart B is a non-refillable polypropylene cartridge containing dry sodium bicarbonate [in compliance with European Pharmacopoeia (Ph. Eur.) and United States Pharmacopoeia (USP)] for hemodialysis. It must be used together with a suitable acid concentrate and water meeting the requirements of the Association for the Advancement of Medical Instrumentation (AAMI). Solcart B must only be used with B. Braun dialysis machines provided with a holder for powder bicarbonate cartridges.
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K Number
K071518Device Name
DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS
Manufacturer
B. BRAUN MEDIZINTECHNOLOGIE GMBH
Date Cleared
2007-08-17
(74 days)
Product Code
KDI, FJI
Regulation Number
876.5860Why did this record match?
Applicant Name (Manufacturer) :
B. BRAUN MEDIZINTECHNOLOGIE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers are designed for single use in acute and chronic hemodialysis.
Device Description
The Diacap LO PS (10, 12 and 15) and Diacap HI PS (10, 12, 15, 18 and 20) are, respectively, conventional permeability and high permeability hemodialyzers. The hollow, polysulfone membrane is housed within a plastic cylinder with four ports: two ports for blood compartment access and two ports for dialysate access.
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K Number
K052764Device Name
DIACAP ULTRA DIALYSIS FLUID FILTER
Manufacturer
B. BRAUN MEDIZINTECHNOLOGIE GMBH
Date Cleared
2006-06-09
(252 days)
Product Code
FKQ, FKP
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
B. BRAUN MEDIZINTECHNOLOGIE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diacap Ultra Dialysis Fluid Filter is intended to filter bacteria and endotoxins from dialysate used for hemodialysis treatments.
Device Description
The Diacap Ultra dialysis fluid filter is sterile, non-pyrogenic dialysis fluid filter for use with machines providing hemodialysis treatments. The device is composed of a hollow core polysulfone and polyvinylpyrrolidone membrane, polycarbonate housing and headers (end-caps) with Hansen type connectors, silicone O-rings, and polyethylene port caps.
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