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Salem Sump Dual Lumen Stomach Tube

FDA 510(k)

Class II (US FDA 510(k))

510(k) K150711

by Covidien

Identifiers

510(k) Number
K150711 FDA 510(k)
FDA Product Code
PIF 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 Salem Sump Dual Lumen Stomach Tube is a gastrointestinal tube with enteral-specific connectors, designed for gastric decompression and drainage. It features two lumens: one large lumen for suctioning gastric contents, irrigation, and medication administration, and a smaller vent lumen to equalize intra-abdominal pressure by allowing atmospheric air to enter. This dual-lumen design supports both continuous and intermittent gastric suctioning, reducing the risk of gastric distension and aspiration. The tube is commonly used in clinical settings requiring prolonged gastric decompression, such as postoperative care, bowel obstruction management, or enteral feeding support.

This device is intended for single-use and is supplied sterile. It is manufactured from PVC and includes centimeter markings to aid in accurate placement. The tube is classified as a Class II medical device under FDA regulations (21 CFR 876.5980) and holds a FDA 510(k) clearance (K150711) for substantial equivalence. It is designed for use in gastroenterology and urology procedures, adhering to MRI safety standards for non-ferromagnetic materials. Storage should follow manufacturer guidelines to maintain sterility and integrity, and it is available in multiple sizes as referenced in regulatory filings.

Frequently asked questions

What is the Salem Sump Dual Lumen Stomach Tube with Multi-functional Port used for?

This tube is designed for gastric decompression and drainage, allowing continuous or intermittent suctioning of gastric contents while preventing distension or aspiration. The dual-lumen design includes one large lumen for suction, irrigation, and medication administration, and a smaller vent lumen to equalize intra-abdominal pressure by allowing air to enter. It is commonly used in postoperative care, bowel obstruction management, or enteral feeding support.

Is the Salem Sump Dual Lumen Tube single-use or reusable?

The tube is explicitly intended for single-use only. This ensures sterility and reduces the risk of contamination or cross-infection, which is critical in clinical settings where gastrointestinal integrity is compromised. Reuse is not recommended by the manufacturer.

What sizes are available for the Salem Sump Dual Lumen Tube?

The device is available in multiple sizes, as referenced in regulatory filings (e.g., FEI numbers like 3000168341, 3005580113, etc.). These sizes are tailored to accommodate different patient anatomies and clinical needs. Exact dimensions or specific size ranges should be verified against the manufacturer’s packaging or technical documentation.

How should the Salem Sump Dual Lumen Tube be stored to maintain integrity?

Storage must follow the manufacturer’s guidelines to preserve sterility and structural integrity. The tube should be kept in its original, sealed packaging until use, protected from moisture, extreme temperatures, and physical damage. Avoid exposing it to direct sunlight or contaminants, as this could compromise its performance or safety.

Is the Salem Sump Dual Lumen Tube MRI-safe?

Yes, the tube is designed from non-ferromagnetic materials, making it MRI-safe for use in magnetic resonance imaging procedures. This ensures compatibility with MRI environments without interference or risk to the patient. Always confirm with the manufacturer’s documentation for specific MRI protocols or restrictions.

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: Salem Sump™ Tube - Cardinal Health, Covidien Salem Sump™ Dual Lumen Stomach Tubes, Salem Sump™ Dual Lumen Stomach Tubes - Bound Tree, Covidien 7771210 Salem Sump Dual Lumen Stomach Tube 10CT

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Covidien

Sources (1)

  • FDA 510(k) K150711 24 fields · synced Oct 5, 2026