BEUDAMED
    Product Code: LZH FDA class 2 21 CFR 880.5725

    Pump, Infusion, Enteral

    General Hospital

    The Enteral Infusion Pump (product code LZH) is a medical device that delivers liquid nutritional formulas directly into the gastrointestinal tract at controlled rates through a feeding tube, used for patients who cannot consume food orally. Regulated under 21 CFR 880.5725 and classified as a Class 2 device, it requires a 510(k) premarket notification and falls under the General Hospital specialty with review by the General Hospital (HO) panel. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    33
    FEI Numbers
    45
    Registration Numbers
    45
    Unique Applicants
    24
    Years Active
    36

    Basic Information

    Product Code
    LZH
    Device Class
    FDA class 2
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

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

    K Number Device Name
    K232205 Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set
    K221603 Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™
    K220230 AMSure Enteral Feeding Pump
    K200051 PUGGLE Enteral Feeding Pump and Feeding Set
    K153074 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
    K143263 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
    K141479 KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
    K131154 ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET;
    K111381 MEDI-SIS SYRINGE INFUSION SYSTEM
    K060316 COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
    K040957 NOA III ENTERAL NUTRITION PUMP
    K040196 KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS
    K031199 ENTERALITE INFINITY ENTERAL FEEDING PUMP
    K031407 ROSS EMBRACE ENTERAL PUMP
    K011868 ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS
    K003047 AMBULATORY ENTERAL NUTRITION PUMP
    K011587 SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP
    K981541 CLEARSTAR ENTERAL NUTRITION PUMP
    K954735 ENTERALITE
    K946168 IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS
    K951429 FLEXIFLO 6.1 ENTERAL NUTRITION PUMP
    K952671 RATESAVER PLUS
    K945964 KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
    K940555 SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION
    K943733 FLEXIFLO SIX ENTERAL NUTRITION PUMP
    K940556 SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP
    K923066 FLO-GARD 2100 - 2M8281M
    K914216 FRENTA II+ ENTERAL FEEDING PUMP
    K913958 FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP
    K913413 KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE
    K901458 NUTRICARE ENFUTEC 1000 ENTERAL FEEDING PUMP
    K891575 COMPAT ENTERAL FEED PUMP 199235 & 199240
    K873119 FLEXIFLO COMPANION ENTERAL NUTRITION PUMP

    FEI Numbers

    This FDA classification entry is associated with 45 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 45 registration numbers. Click on an entry to view related FDA registrations.