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dry ac acid concentrate mix for bicarbonate hemodialysis
Gambro Renal Products
Summary: The dry acid concentrate mix by Gambro Renal Products is used in bicarbonate hemodialysis. It is FDA 510k cleared and linked to 5 studies, though none directly related to the device.
FDA Clearance Information
Pathway
510K
Number
K011368 ↗
Decision Date
August 2, 2001
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The dry acid concentrate mix for bicarbonate hemodialysis was cleared by the FDA via the 510k pathway on August 2, 2001. It is manufactured by Gambro Renal Products and classified as a Class 2 device.
What It Is
The dry acid concentrate mix is a component used in bicarbonate hemodialysis to help maintain the acid-base balance in patients undergoing dialysis. It is designed for use in dialysis machines to facilitate the removal of waste products from the blood.
Clinical Applications
This device is commonly used in clinical settings for patients requiring hemodialysis due to renal failure. It is an integral part of the dialysis process, ensuring the correct acid-base balance is achieved during treatment.
Evidence Summary
The available literature includes 5 studies, though none directly pertain to the dry acid concentrate mix. The studies range from 2013 to 2025 and cover various unrelated topics.
Reported Outcomes
Published studies report no direct outcomes related to the dry acid concentrate mix for bicarbonate hemodialysis. The linked studies focus on unrelated topics such as livestock nutrition and dairy cow milk synthesis.
Safety Profile
Reported complications include no specific safety data related to the dry acid concentrate mix. The studies provided do not address safety concerns for this device.
Evidence Limitations
The evidence provided does not directly address the efficacy or safety of the dry acid concentrate mix. Further research is needed to evaluate its specific clinical outcomes and potential complications.
Frequently Asked Questions
What are the clinical indications for dry acid concentrate mix?
The dry acid concentrate mix is indicated for use in bicarbonate hemodialysis to maintain acid-base balance in patients undergoing dialysis.
What outcomes have been reported in clinical studies?
No specific outcomes related to the dry acid concentrate mix have been reported in the provided studies.
What complications have been reported?
No complications specific to the dry acid concentrate mix have been reported in the provided evidence.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.