LH 500 Enteral Feeding Gravity Bag Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K011343 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 LH 500 Enteral Feeding Gravity Bag Set is a device used for gravity feeding of enteral nutrition to patients. It provides a gravity-fed system for delivering nutrients without requiring an electronic feeding pump.
The device is supplied by Lh Medical Products, Inc. and has FDA 510(k) clearance K011343 with product code KNT. It is designed for use in home healthcare, hospitals, and long-term care settings.
Frequently asked questions
What is the LH 500 Enteral Feeding Gravity Bag Set used for?
The LH 500 Enteral Feeding Gravity Bag Set is designed for gravity feeding of enteral nutrition to patients, providing a system for delivering nutrients without requiring an electronic feeding pump. It is suitable for use in home healthcare, hospitals, and long-term care settings.
How is the LH 500 Enteral Feeding Gravity Bag Set supplied?
The LH 500 Enteral Feeding Gravity Bag Set is supplied by Lh Medical Products, Inc. It is designed as a complete system for gravity feeding enteral nutrition, making it convenient for healthcare providers and caregivers to set up and use.
What is the regulatory status of the LH 500 Enteral Feeding Gravity Bag Set?
The LH 500 Enteral Feeding Gravity Bag Set has FDA 510(k) clearance K011343 with product code KNT. It was determined to be substantially equivalent to predicate devices through the traditional clearance process.
In what settings can the LH 500 Enteral Feeding Gravity Bag Set be used?
The LH 500 Enteral Feeding Gravity Bag Set is designed for use in multiple healthcare settings including home healthcare, hospitals, and long-term care facilities, making it versatile for different patient care environments.
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: LH 500 ENTERAL FEEDING GRAVITY BAG SET - Innolitics, FDA Browser - Cleared 510 (K) - LH 500 ENTERAL FEEDING GRAVITY BAG SET ..., LH 500 ENTERAL FEEDING GRAVITY BAG SET 510(k) K011343 - fda.report, Gravity Feeding Bags & Sets | Vitality Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011343 | Class II | Active |
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Manufacturer
- Manufacturer
- Lh Medical Products, Inc.
Sources (1)
- FDA 510(k) K011343 24 fields · synced Sep 24, 2026