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510(k) Data Aggregation
K Number
K963440Device Name
DIALOG DIALYSIS MACHINE
Manufacturer
B. BRAUN MEDICAL AG
Date Cleared
1998-06-26
(665 days)
Product Code
KDI
Regulation Number
876.5860Why did this record match?
Applicant Name (Manufacturer) :
B. BRAUN MEDICAL AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the device is for Volume controlled ultrafiltration and infusion of heparin through a blood pump for the treatment of renal failure or toxic Conditions. This device may be used for High. Flux Hemodialysis.
Device Description
The Dialog Dialysis Machine is an artificial kidney system used for the treatment of patients with renal failure or toxic conditions. The device consists of an extracorporeal blood system for the separation of substances in solutions via a semipermeable membrane. The system allows for volume controlled ultfiltration and/or infusion of heparin through a blood pump by utilizing a standard double needle or optional single needle dialysis procedure.
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K Number
K962084Device Name
OMNICAN SYRINGE
Manufacturer
B. BRAUN MEDICAL AG
Date Cleared
1997-02-10
(257 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
B. BRAUN MEDICAL AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Omnican Syringe is designed to be used for subcutaneous, injection.
Device Description
The Omnican Syringe is composed of materials that have been tested in accordance with ISO 10993 for plastics and determined to be sultable for the intended use of this product. The syringes are packaged in boxes of 100 each. Each box contains a magnifier to assist in reading the scale on the syringe barrel.
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