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510(k) Data Aggregation
K Number
K010760Device Name
ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS
Manufacturer
ADVANCED RENAL TECHNOLOGIES, INC.
Date Cleared
2001-06-11
(90 days)
Product Code
KPO
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED RENAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000792Device Name
CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX
Manufacturer
ADVANCED RENAL TECHNOLOGIES, INC.
Date Cleared
2000-06-08
(90 days)
Product Code
KPO
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED RENAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K980659Device Name
DRYALYSATE CONCENTRATE
Manufacturer
ADVANCED RENAL TECHNOLOGIES, INC.
Date Cleared
1998-06-11
(111 days)
Product Code
KPO
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED RENAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DRYalysate™ Concentrate is intended for use for patients being treated by hemodialysis. The primary patient population that will use this device are those who suffer from loss of kidney function and who are prescribed acute or chronic hemodialysis. The indications for use of this product are exactly the same as those for currently marketed dialysate concentrates.
Device Description
The device consists of packaged dry chemicals which, when mixed and dissolved with AAMI quality water, according to the directions for use, makes an acid concentrate that can be used by current proportioning type hemodialysis machines to make dialysate.
DRYalysate™ Concentrate will be packaged and sold in two convenient boxed sizes; a 'single dose' package designed to make enough dialysate concentrate (5 Liters) for one patient for one treatment and a 'bulk' package which contains enough powder to make 50 liters of dialysate at a time.
Once the package of chemicals is mixed according to the instructions for use, the resulting liquid concentrate is used in the hemodialysis process in proportioning type hemodialysis machines in exactly the same way that existing concentrates are used.
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