BEUDAMED
    Product Code: PIF FDA class 2 21 CFR 876.5980

    Gastrointestinal Tubes With Enteral Specific Connectors

    Gastroenterology, Urology

    Gastrointestinal Tubes with Enteral Specific Connectors are feeding tubes designed to facilitate enteral-specific connections, incorporating connectors compliant with enteral feeding standards to reduce the risk of misconnection errors with other medical tubing systems. They are FDA Class 2 devices regulated under 21 CFR 876.5980, requiring 510(k) premarket notification, within the Gastroenterology and Urology (GU) specialty. The product code is PIF. These devices are not implants and are not life-sustaining.

    View on FDA
    510(k)s
    50
    FEI Numbers
    87
    Registration Numbers
    87
    Unique Applicants
    35
    Years Active
    12

    Research product code PIF 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
    PIF
    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

    To facilitate enteral specific connections.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 50 510(k) clearances via K numbers.

    K Number Device Name
    K254170 Percutaneous Endoscopic Gastrostomy (PEG) Kit
    K242917 Enteral Drainage System, Enteral Medicine straw
    K250481 Extension Feeding Set with ENFit™ Connectors
    K240052 Disposable Enteral Feeding Sets
    K233034 Mobility+ Enteral Feeding System OTC
    K230326 ENFit to ENFit Extension Sets
    K232046 Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
    K222773 Feeding Tube
    K223683 EnteraLoc Flow
    K222678 Mobility+ Enteral Feeding System
    K213258 Nasogastric Feeding Tubes - ENFit Port - PVC
    K213174 Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
    K213356 Entuit PEG, Entuit PEGJ
    K210854 Enteral Feeding Set
    K210598 Pediatric Nasogastric Feeding Tubes - Single ENFit Port
    K203633 Enteral Extension Sets
    K210971 EnteraLoc Flow
    K201741 Gabriel 3 Way EnFit Valve
    K202357 Nutricare Clear-ISOSAF Nasogastric Feeding Tube
    K192991 Vesco Medical Extension Feeding Set
    K200082 BD Univia RightFit Enteral Extension Sets and Transitional Adapters
    K191759 Medline Quick Switch Valve with ENFit Connector
    K191784 Gabriel Feeding Tube with Balloon, and EnFit Connector
    K190923 Salem Sump Dual Lumen Stomach Tube with ENFit Connection
    K190414 Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
    K190310 U Deliver Bolink ENFit Enteral Feeding Sets
    K181787 Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
    K190327 ENConnect 40 mm Screw Cap to ENPlus Adapter
    K180708 Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit
    K181276 CONOD Enteral Feeding Sets
    K170162 Vesco Medical Nasoenteric Feeding Tubes
    K170555 U Deliver Bolink ENFit Enteral Feeding Sets
    K171347 Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
    K163586 Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
    K153688 Edi Catheter ENFit
    K160642 Medline ENFit Syringe
    K161003 EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector
    K151503 NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE
    K150711 Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
    K150084 Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
    K150679 EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
    K150286 Medline Enteral Feeding Sets
    K143018 Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors
    K142989 Mini ONE Enteral Extension Set
    K142539 EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set
    K142297 Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set
    K142075 BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE
    K142012 FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS
    K141753 AQUARIUS NASAL FEEDING TUBE
    K140947 COMPAT ENTERAL DELIVERY PUMP SETS

    FEI Numbers

    This FDA classification entry is associated with 87 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 87 registration numbers. Click on an entry to view related FDA registrations.