FDA.report

Elastomeric infusion pump system

Definition
An assembly of devices that provides continuous and/or intermittent percutaneous infusion of a prescribed medicated solution to a patient through forces from elastic material. It typically consists of an elastomeric chamber (various sizes predetermine the flow and volume) that is filled with the solution using a dedicated filling device and/or syringe to create a pressure, tubing, particulate/air-eliminating filter, a flow restrictor, and a connector at the distal end for connection to the patient's access device. It may be used for general infusion, antibiotic delivery, chemotherapy, or pain management in either a healthcare facility or in the home. This is a single-use device.
GUDID devices
310
Last updated
2026-02-11 15:06:50

Related Product Codes

CodeDeviceSpecialtyClassDevices
MEBPump, Infusion, ElastomericGeneral Hospital2309
QLFOn-Body InjectorGeneral Hospital21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
28859299198143SMARTeZ Pump KVOEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED4981412026-02-03
48859299198123SMARTeZ Pump KVOEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED4981212026-02-03
48859299198130SMARTeZ Pump KVOEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED4981312026-02-03
18859299101177SMARTeZ PumpEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED4811712025-11-14
78859299100042SMARTeZ PumpEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED4800462025-11-14
48859299198116SMARTeZ Pump KVOEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED4981112025-09-11
00850050591030MediFloNDC HOMECARE LLCWP-MDL3000602025-07-30
00857800006073MediFloNDC HOMECARE LLCWP-MDE101000-52025-07-30
00857800006202MediFloNDC HOMECARE LLCWP-MDE102000-52025-07-30
58859299121715SMARTeZ PumpEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED4810722025-06-11
58859299121722SMARTeZ PumpEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED4811022025-06-11
10810110920290IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM050050S2025-04-16
10810110920306IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM100050S2025-04-16
10810110920337IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM250175S2025-04-16
10810110920344IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM250250S2025-04-16
10810110920351IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM400100S2025-04-16
10810110920368IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM400200S2025-04-16
10810110920375IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM500250S2025-04-16
10810110920382IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM200100S2025-04-16
10810110920399IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM200200S2025-04-16
10810110920405IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM250100S2025-04-16
10810110920412IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM250125S2025-04-16
10810110920429IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM250500S2025-04-16
10810110920436IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM250050S2025-04-16
10810110920443IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM270175S2025-04-16
10810110920450IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM100002L2025-04-16
10810110920467IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM100005L2025-04-16
10810110920481IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM270001L2025-04-16
10810110920498IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM270002L2025-04-16
10810110920504IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM270004L2025-04-16
10810110920511IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM270005L2025-04-16
60810110920318IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM100100S2025-04-16
60810110920325IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM100200S2025-04-16
60810110920486IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM270010L2025-04-16
10810110920528IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM500020L2025-04-16
10810110920535IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM100002C2025-04-16
10810110920542IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM270002C2025-04-16
10810110920559IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM270005C2025-04-16
10810110920566IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM270010C2025-04-16
10810110920573IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM300006C2025-04-16
10810110920597IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM125005C2025-04-16
10810110920603IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM125005L2025-04-16
10810110920610IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.IM060005L2025-04-16
28859299117496SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED480012BAX2024-05-31
28859299117502SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED480032BAX2024-05-31
28859299117519SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED480042BAX2024-05-31
28859299117533SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED480052BAX2024-05-31
28859299117540SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED480062BAX2024-05-31
28859299117557SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED480072BAX2024-05-31
28859299117564SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED480082BAX2024-05-31
28859299117571SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED480092BAX2024-05-31
28859299117588SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED480112BAX2024-05-31
28859299117595SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED480132BAX2024-05-31
28859299117601SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED480142BAX2024-05-31
28859299117618SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED480162BAX2024-05-31
28859299117625SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED480182BAX2024-05-31
28859299117632SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED480612BAX2024-05-31
28859299117649SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481013BAX2024-05-31
28859299117663SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481022BAX2024-05-31
28859299117670SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481033BAX2024-05-31
28859299117687SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481043BAX2024-05-31
28859299117700SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481052BAX2024-05-31
28859299117724SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481062BAX2024-05-31
28859299117748SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481072BAX2024-05-31
28859299117755SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481082BAX2024-05-31
28859299117762SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481093BAX2024-05-31
28859299117779SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481102BAX2024-05-31
28859299117786SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481122BAX2024-05-31
28859299117793SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481132BAX2024-05-31
28859299117809SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481142BAX2024-05-31
28859299117816SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481152BAX2024-05-31
28859299117823SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481172BAX2024-05-31
28859299117830SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481232BAX2024-05-31
28859299117847SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED481242BAX2024-05-31
28859299117854SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED484012BAX2024-05-31
28859299117861SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED484022BAX2024-05-31
28859299117878SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED484032BAX2024-05-31
28859299117885SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED484042BAX2024-05-31
28859299117892SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED484052BAX2024-05-31
28859299117908SimplFusorEPIC INTERNATIONAL(THAILAND) COMPANY LIMITED484252BAX2024-05-31