Dextrolyte II, Manual Administration Set 48-1032-1
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K900005 FDA 510(k)
- FDA Product Code
- KDJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5630 FDA 510(k)
- Regulation Number
- 876.5630 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dextrolyte II, Manual Administration Set 48-1032-1 is a disposable administration set designed for peritoneal dialysis. It is classified as a Class II medical device under product code KDJ with special controls. This device facilitates the manual administration of dialysis solutions during peritoneal dialysis procedures.
The administration set is supplied as a single-use device and is not intended for reuse. It is manufactured by National Medical Care, Medical Products Div., Inc. and received FDA 510(k) clearance with number K900005 on March 2, 1990. The device is regulated under FDA regulation number 876.5630 and is classified under the medical specialty of Gastroenterology and Urology.
Frequently asked questions
What is the Dextrolyte II Manual Administration Set used for?
The Dextrolyte II Manual Administration Set is designed for peritoneal dialysis procedures, facilitating the manual administration of dialysis solutions. It is a disposable device intended for single use only.
Is the Dextrolyte II Administration Set reusable?
No, the Dextrolyte II Manual Administration Set is supplied as a single-use device and is not intended for reuse. It should be discarded after one use to ensure patient safety and device effectiveness.
What is the regulatory status of the Dextrolyte II Administration Set?
The Dextrolyte II Manual Administration Set is a Class II medical device that received FDA 510(k) clearance with number K900005 on March 2, 1990. It is regulated under FDA regulation number 876.5630 and classified under the medical specialty of Gastroenterology and Urology.
Who manufactures the Dextrolyte II Manual Administration Set?
The Dextrolyte II Manual Administration Set is manufactured by National Medical Care, Medical Products Div., Inc., located in Rockleigh, New Jersey. The company received FDA clearance for this device in 1990.
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: Dextrolyte Ii, Manual Administration Set 48-1032-1, K900005 - DEXTROLYTE II | FDA 510 (k), PDF K900005 - Dextrolyte Ii, Manual Administration Set 48-1032-1, 510 (k) Premarket Notification - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K900005 | Class II | Active |
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Manufacturer
- Manufacturer
- National Medical Care, Medical Products Div., Inc.
Sources (1)
- FDA 510(k) K900005 24 fields · synced Sep 25, 2026