MMG Enteral Feeding Administration Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K854660 FDA 510(k)
- FDA Product Code
- KNT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5980 FDA 510(k)
- Regulation Number
- 876.5980 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MMG Enteral Feeding Administration Set is a medical device designed for the administration of enteral nutrition, fluids, or medications directly into the gastrointestinal tract. It is classified as an enteral feeding tube accessory, facilitating controlled delivery of substances via nasogastric, orogastric, or gastric tubes. The set ensures proper flow and reduces the risk of contamination or clogging during feeding procedures. Its construction adheres to standards for safe, sterile use in clinical settings requiring enteral support.
This single-use device is supplied sterile and intended for one-time use in hospital, clinic, or home healthcare environments. It is regulated under FDA 510(k) clearance (K854660) and falls under the product code KNT for enteral feeding accessories. Storage requires protection from moisture and extreme temperatures, and it must be inspected for integrity before use. No MRI safety information is specified, and its reusable components, if any, are not detailed in the regulatory data.
Frequently asked questions
What is the MMG Enteral Feeding Administration Set used for?
The MMG Enteral Feeding Administration Set is designed to deliver enteral nutrition, fluids, or medications directly into the gastrointestinal tract through nasogastric, orogastric, or gastric tubes. It ensures controlled flow and minimizes the risk of contamination or blockages during feeding procedures, making it ideal for hospital, clinic, or home healthcare environments where enteral support is required.
Is the MMG Enteral Feeding Administration Set sterile and single-use?
Yes, the MMG Enteral Feeding Administration Set is supplied sterile and intended for one-time use only. This design reduces the risk of cross-contamination and ensures patient safety, as reuse is not recommended based on the provided regulatory data.
How should the MMG Enteral Feeding Administration Set be stored?
The set must be stored in a way that protects it from moisture and extreme temperatures. Before use, inspect the packaging for any signs of damage or compromise to ensure sterility and integrity. Proper storage conditions help maintain the device’s performance and safety for its intended single-use application.
What regulatory approval does the MMG Enteral Feeding Administration Set hold?
The MMG Enteral Feeding Administration Set is cleared by the FDA under 510(k) clearance (K854660) and falls under product code KNT for enteral feeding accessories. This classification confirms its compliance with U.S. regulatory standards for enteral feeding tube accessories.
Are there any reusable components in the MMG Enteral Feeding Administration Set?
The regulatory data does not specify any reusable components for the MMG Enteral Feeding Administration Set. As a single-use device, it is intended to be discarded after one use to prevent contamination and ensure patient safety.
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: THE MMG ENTERAL FEEDING ADMINISTRATION SET (K854660) — FDA 510 (k ..., Establishment Registration & Device Listing - Food and Drug Administration, MEDICAL TECHNOLOGIES OF GEORGIA, INC. - fda.report, Medical-Technologies-Of-Georgia FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K854660 | Class II | Active |
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Manufacturer
- Manufacturer
- Medical Technologies of Georgia
Sources (1)
- FDA 510(k) K854660 24 fields · synced Oct 5, 2026