NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate …
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191474 FDA 510(k)
- FDA Product Code
- KPO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5820 FDA 510(k)
- Regulation Number
- 876.5820 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
NaturaLyte Dry Bicarbonate Concentrate is a dialysate concentrate for hemodialysis (liquid or powder) used as a bicarbonate buffer solution in extracorporeal hemodialysis. It is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure.
The device is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription. It is supplied in Rx-10 Bag, Rx-12 Bag, and Carton formats and is authorized under FDA 510(k) clearance K191474.
Frequently asked questions
What is NaturaLyte Dry Bicarbonate Concentrate used for?
NaturaLyte Dry Bicarbonate Concentrate is used as a bicarbonate buffer solution in extracorporeal hemodialysis for patients with acute and chronic renal failure. It is one component in preparing dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription, helping to maintain proper acid-base balance during treatment.
How is NaturaLyte Dry Bicarbonate Concentrate supplied and what formats are available?
NaturaLyte Dry Bicarbonate Concentrate is supplied in three formats: Rx-10 Bag, Rx-12 Bag, and Carton. These formats allow flexibility in dialysis setup and are designed for use in preparing dialysate as part of hemodialysis therapy, with each format containing the dry concentrate that is reconstituted with water to form the bicarbonate component of dialysate.
Is NaturaLyte Dry Bicarbonate Concentrate sterile and intended for single use?
NaturaLyte Dry Bicarbonate Concentrate is not supplied sterile, as it is a dry powder concentrate that is reconstituted with water to form dialysate. The resulting dialysate solution is used immediately in the hemodialysis machine and is not stored for reuse. The device itself is intended for single use in the sense that each batch is reconstituted and used once per treatment session, though sterility is not claimed for the dry product.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NaturaLyte Bicarbonate Acid - FMCNA, NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry ..., PDF NaturaLyte-Dry-Bicarbonate-08-4112-2_Rx12 RD000449_Rev. 12.0_9 Aug 2019
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191474 | Class II | Active |
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Manufacturer
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
Sources (1)
- FDA 510(k) K191474 24 fields · synced Sep 22, 2026