Dextrolyte II, W/5 Prong Manifold No. 48-1100-6
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K900141 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)
Dextrolyte II, W/5 Prong Manifold No. 48-1100-6 is a disposable administration set for peritoneal dialysis. It is classified as a Class II device under product code KDJ and is designed to facilitate the delivery of dialysis fluid during peritoneal dialysis procedures. The device includes a five-prong manifold configuration as specified in its model number.
The device is supplied as a single-use, sterile unit intended for clinical settings where peritoneal dialysis is performed. It is regulated under 21 CFR 876.5630 and was cleared through the FDA 510(k) process under reference K900141. Storage conditions and specific handling instructions are not detailed in the available specifications.
Frequently asked questions
What is the Dextrolyte II 48-1100-6 used for?
It is a disposable administration set for peritoneal dialysis, designed to deliver dialysis fluid during peritoneal dialysis procedures in clinical settings.
How is the Dextrolyte II supplied?
It is supplied as a single-use, sterile unit. Each unit is intended for one patient use and should not be reused or resterilized.
What is the manifold configuration of this device?
The device features a five-prong manifold configuration, as indicated in its model number 48-1100-6, which helps manage multiple fluid lines during dialysis.
Is the Dextrolyte II reusable?
No, it is a single-use device. Reuse or reprocessing is not supported, as it is designed for one-time clinical use to ensure sterility and patient safety.
What regulatory pathway was used for this device?
It was cleared through the FDA 510(k) process under reference K900141, classified as a Class II device under product code KDJ and regulated under 21 CFR 876.5630.
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, W/5 Prong Manifold No. 48-1100-6, DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6 510 (k) K900141 - FDA ..., K900141 - DEXTROLYTE II | FDA 510 (k), K900142 - DEXTROLYTE II | FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K900141 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- National Medical Care, Medical Products Div., Inc.
Sources (1)
- FDA 510(k) K900141 24 fields · synced Sep 27, 2026