BEUDAMED
    Product Code: ONB FDA class 2 21 CFR 880.5440

    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

    General Hospital

    The Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB) is a Class 2 device regulated under 21 CFR 880.5440 in the General Hospital specialty (HO), cleared via 510(k). It is designed to reconstitute and transfer antineoplastic and other hazardous drugs in healthcare settings to reduce exposure of healthcare personnel to chemotherapy agents during drug preparation and administration. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    41
    FEI Numbers
    40
    Registration Numbers
    40
    Unique Applicants
    13
    Years Active
    13

    Research product code ONB 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
    ONB
    Device Class
    FDA class 2
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

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

    Definition

    Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 41 510(k) clearances via K numbers.

    K Number Device Name
    K251722 ProSeal™ Transfer Injector (421120, 421130, 421140)
    K253033 Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
    K250059 BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)
    K251411 Chemfort Female Luer Lock Adaptor
    K251340 ProSeal™ Bag Spike with Additive Port (423370ST, 423370)
    K243976 ZeroClear™ Bag Access (423100)
    K240517 ProSeal™ Vented Universal Vial Adaptor
    K241988 ProSeal™ Closed System Bag Access
    K241735 ProSeal™ In Line Pump Set (423850)
    K241823 ToxiSeal™ Vial Adaptor
    K241476 ToxiSeal™ Vial Adaptor with External Flip Balloon
    K240433 ProSeal™ Injection Site Extended Male Luer Lock (422140)
    K240171 ProSeal™ Injector Plus (Model no. 421050)
    K222929 ToxiSeal Vial Adapter with External Balloon
    K231286 Chemfort® Catheter Adaptor
    K223076 BD Texium™ Closed Male Luer
    K221513 Equashield Closed System Transfer Device
    K201460 Closed System Transfer Device
    K210707 OnGuard2 Chemfort Closed Administration (CADM)
    K201422 Arisure Closed System Drug Transfer Device (CSTD)
    K201142 TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set
    K201099 BD PhaSeal Optima Closed System Drug Transfer Device
    K192075 ProSeal™ Closed System drug Transfer Device (CSTD)
    K192866 Chemfort CSTD
    K190157 Diana ChemoClave Transfer Set
    K181221 BD PhaSeal Optima Closed System Transfer Device
    K180489 TEVADAPTOR Closed Drug Reconstitution and Transfer System
    K173477 ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
    K180574 Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor
    K170110 Diana Medication Transfer Set
    K172499 NEOSHIELD
    K170706 Equashield Closed System drug Transfer Device (CSTD)
    K170680 TEVADAPTOR Closed Drug Reconstitution and Transfer System
    K150219 Equashield Closed System drug Transfer Device (CSTD)
    K150486 Halo
    K141448 TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
    K140591 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR
    K132899 EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD)
    K131549 CHEMOLOCK, CHEMOLOCK PORT
    K130197 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55
    K123213 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE

    FEI Numbers

    This FDA classification entry is associated with 40 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 40 registration numbers. Click on an entry to view related FDA registrations.