Nutrisafe Enteral Feeding Tube

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K981629 ↗

FDA Product Code

FPD

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What clinical settings is the Nutrisafe Enteral Feeding Tube primarily used in, and why is this relevant for clinicians?

  The Nutrisafe Enteral Feeding Tube is primarily used in gastroenterology and urology settings, as indicated by its regulatory classification and advisory committee designation. This is relevant for clinicians because it confirms the tube’s intended use for delivering enteral nutrition in patients with gastrointestinal or urological conditions, such as swallowing disorders, obstructions, or long-term nutritional support. The specialized focus ensures compatibility with procedures and patient care protocols in these fields.

• How do I know if the Nutrisafe Enteral Feeding Tube is sterile and safe for immediate clinical use upon opening?

  The Nutrisafe Enteral Feeding Tube is supplied sterile and intended for single-use, meaning it is pre-sterilized and packaged to maintain sterility until use. This ensures safety and reduces infection risk, as it eliminates the need for reprocessing or additional sterilization steps in the clinical setting.

• Are there multiple sizes or configurations available for the Nutrisafe Enteral Feeding Tube, and how might this affect my selection?

  Yes, the Nutrisafe Enteral Feeding Tube comes in multiple sizes and configurations, as evidenced by the diverse list of FEI numbers (e.g., 3005483737, 3007084575, etc.). These variations allow clinicians to select the appropriate length, diameter, or tip design based on patient anatomy, procedural requirements, or specific medical needs—such as nasogastric, nasojejunal, or percutaneous placement.

• What regulatory pathway does the Nutrisafe Enteral Feeding Tube follow, and what does this mean for purchasing or prescribing it?

  The Nutrisafe Enteral Feeding Tube follows the FDA 510(k) clearance pathway, with a decision of Substantially Equivalent (SESE) issued in 1999 under product code FPD (Tube, Feeding). This means it has been reviewed and deemed comparable to a legally marketed predicate device, ensuring compliance with FDA standards for safety and effectiveness. For buyers or clinicians, this confirms the device meets regulatory requirements for use in enteral nutrition delivery.

• How should I store the Nutrisafe Enteral Feeding Tube to maintain its integrity before use?

  While the device data does not specify storage conditions, as a sterile, single-use medical device, it should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or contaminants. Follow manufacturer instructions (available from Schiff & Co.) for optimal shelf life and sterility preservation, as improper storage could compromise the tube’s integrity or sterility before use.