BEUDAMED
    Product Code: PNR FDA class 2 21 CFR 876.5980

    Enteral Syringes With Enteral Specific Connectors

    Gastroenterology, Urology

    The Enteral Syringes With Enteral Specific Connectors (product code PNR) are Class 2 gastroenterology and urology devices used to deliver nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors, regulated under 876.5980. They require 510(k) clearance and are designed to reduce misconnection risks through enteral-specific connector standards. The devices are not implants and are not life-sustaining.

    View on FDA
    510(k)s
    33
    FEI Numbers
    51
    Registration Numbers
    51
    Unique Applicants
    22
    Years Active
    11

    Research product code PNR in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    PNR
    Device Class
    FDA class 2
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 33 510(k) clearances via K numbers.

    K Number Device Name
    K253268 Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
    K251585 Profoject™ Enteral Feeding Syringe
    K243652 Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE)
    K231300 Nutricair Enteral Syringe with ENFit
    K222772 Oral/Enteral Syringe with ENFit connector
    K211661 ENFit enteral syringes (NUTRIFIT)
    K211593 Enteral Pump Syringe
    K203613 ENFit Reusable Enteral Syringe
    K211025 Oral/Enteral Syringe with ENFit connector
    K203410 ENFit Disposable Enteral Syringe
    K210621 Oral/Enteral Syringe
    K202285 Medline ENfit OTC Feeding Syringe
    K200557 Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)
    K193657 Disposable Enteral Feeding Syringe with Enfit Connector
    K190502 ENFit Oral / Enteral Syringe
    K183540 Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)
    K182649 Enteral Feeding Syringes with Enfit Connectors
    K181426 Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)
    K171857 AMSure® Enteral Feeding Syringe with ENFit Tip
    K170371 DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe
    K170672 Tamper Evident Cap For use with ENFit Syringes
    K161979 ENFit enteral syringe
    K161141 ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT
    K161811 Medela Low Dose Enteral Syringe
    K160855 U&U Enteral Syringe
    K162188 Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)
    K161963 Monoject Enteral Syringe with ENFit Connector
    K161045 Monoject
    K161039 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
    K160419 Monoject Enteral Feeding Syringe with ENFit Connector
    K152857 NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps
    K143344 NeoMed NeoConnect Enteral Syringes with ENFit Connector
    K142128 KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR

    FEI Numbers

    This FDA classification entry is associated with 51 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 51 registration numbers. Click on an entry to view related FDA registrations.