FDA.reportPublic FDA data

Bedside infusion pump, single-channel

Definition
An electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.
GUDID devices
108
Last updated
2026-11-01 02:55:24

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10885403532948BD Alaris™ PCU Module, Model 8015CAREFUSION 303, INC.80152026-10-22
00856038001942IradimedIRADIMED CORP.38702026-10-08
10885403519437BD Alaris™ PCU Module, Model 8015CAREFUSION 303, INC.80152026-10-08
10885403533211BD Alaris™ PCU Model 8015CAREFUSION 303, INC.80152026-10-08
10885403533297BD Alaris™ PCU Model 8015CAREFUSION 303, INC.80152026-10-08
10885403533426BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.81002026-10-08
10885403535215BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.81002026-10-08
10885403542930BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.81002026-10-08
00197886011234Novum IQBAXTER HEALTHCARE CORPORATION40700BAXUSL2025-08-25
00197886013177Novum IQBAXTER HEALTHCARE CORPORATION40700BAXUSD2025-08-25
00197886013184Novum IQBAXTER HEALTHCARE CORPORATION40700BAXUSRF2025-08-25
00197886013191Novum IQBAXTER HEALTHCARE CORPORATION40700BAXUSRP2025-08-25
00814371020013Z-800FZYNO MEDICAL LLCZ-800F2015-10-13
00814371020020Z-800WZYNO MEDICAL LLCZ-800W2015-10-13
00814371020037Z-800WFZYNO MEDICAL LLCZ-800WF2015-10-13
00814371020044NimbusZYNO MEDICAL LLCNimbus2015-10-13
00816989020126Klein Infiltration Pump IIHK SURGICAL INC.KIP-II2020-06-16
00816989020133ReShape Infiltration Pump HK SURGICAL INC.KIP-II-RS2020-06-16
00816989020140Klein Touch PumpHK SURGICAL INC.KTP2020-06-16
00817708022957Tetra MicroEMED TECHNOLOGIES CORPORATIONTM-202026-02-24
00817708022971Tetra MicroEMED TECHNOLOGIES CORPORATIONFP-00102142026-02-24
00817708023374Tetra MicroEMED TECHNOLOGIES CORPORATIONFP-00102152026-02-24
00817708023428Tetra MicroEMED TECHNOLOGIES CORPORATIONFP-00102162026-02-24
00817708023435Tetra MicroEMED TECHNOLOGIES CORPORATIONTM-502026-02-24
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCAvoset Infusion Pump2026-02-24
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.0017002023-12-01
10887787005827PlumICU Medical, Inc.19684012016-09-01
10887787008859PlumICU Medical, Inc.19556382016-09-01
10887787008873PlumICU Medical, Inc.19557382016-09-01
10887787008897PlumICU Medical, Inc.19685282016-09-01
10887787008903PlumICU Medical, Inc.19683282016-09-01
10887787008927PlumICU Medical, Inc.19671382016-09-01
10887787008934HospiraICU Medical, Inc.19721282016-09-01
10887787009009PlumICU Medical, Inc.19729282016-09-01
10887787009016PlumICU Medical, Inc.19720282016-09-01
10887787009023PlumICU Medical, Inc.11879122016-09-01
17290109150106Sapphire M.T. Infusion Kit- USEITAN MEDICAL LTD17000-028-00612016-09-01
17290109150120Sapphire M.T. with Bolus and Splitter Kit -USEITAN MEDICAL LTD17000-028-00622016-09-01
17290109150137Sapphire Epidural Infusion Kit-USEITAN MEDICAL LTD17000-031-00272016-09-01
17290109150151SapphirePlus Infusion Kit - USEITAN MEDICAL LTD17000-033-00012016-09-01
17290109150229SapphirePlus Infusion Kit - USEITAN MEDICAL LTD17000-033-00012018-02-22
17290109152742Avoset Kit - USEITAN MEDICAL LTD17000-036-00042025-03-05
17290109154265Sapphire M.T Infusion Pump Kit – USEITAN MEDICAL LTD17000-028-00722022-05-11
17290109154272Sapphire Epidural Infusion Pump Kit – USEITAN MEDICAL LTD17000-031-00352022-05-15
17290109154289Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTD17000-028-0072-S2022-05-15
17290109155149Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTD17000-031-10402023-09-05
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTD17000-028-10452024-09-04
10885403211423Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.81002025-12-19
10885403423208Alaris™ Syringe Module, Model 8110CAREFUSION 303, INC.81002025-12-19
00816989021468HK Klein Infiltration Pump+HK SURGICAL INC.KIP-II+2025-09-29
50197886011239Novum IQBAXTER HEALTHCARE CORPORATION40700BAXUSL2025-08-25
50197886013172Novum IQBAXTER HEALTHCARE CORPORATION40700BAXUSD2025-08-25
50197886013189Novum IQBAXTER HEALTHCARE CORPORATION40700BAXUSRF2025-08-25
50197886013196Novum IQBAXTER HEALTHCARE CORPORATION40700BAXUSRP2025-08-25
10885403519291BD® Alaris™ PCU Model 8015CAREFUSION 303, INC.80152025-06-25
M335400011ICU Medical, INC.ICU MEDICAL, INC.4000104012025-04-28
M335400031ICU Medical, INC.ICU MEDICAL, INC.4000204032025-04-28
27290109152749Avoset Kit - USEITAN MEDICAL LTD17000-036-00042025-03-05
00811505030467Ivenix Infusion SystemFresenius Kabi AG030-0028-082024-12-06
27290109155306Sapphire M.T. Pump Kit CEITAN MEDICAL LTD17000-028-10452024-09-04
04260166374087INTELLAGEN™ Irrigation Pump KitStockert GmbH204022024-09-01
04260166374117INTELLAGEN™ Irrigation PumpStockert GmbH204052024-09-01
00816989021437HK Klein TDD PumpHK SURGICAL INC.KTDD2024-08-29
10885403519284BD® Alaris™ PCU Model 8015CAREFUSION 303, INC.80152024-05-24
00862492000353Avoset-Optum Homecare InfusionOPTUMHEALTH CARE SOLUTIONS, INC.Pump Avoset Infusion2024-04-24
05413765851797Novum IQBAXTER HEALTHCARE CORPORATION40700BAXUS2024-04-10
10885403519215BD® Alaris™ PCU Model 8015CAREFUSION 303, INC.80152024-04-01
17290109155095Sapphire MT Infusion Kit 16 – USEITAN MEDICAL LTD17000-028-10392024-02-25
30815112021390CardioGen-82 Infusion System Model 1700BRACCO DIAGNOSTICS INC0017002023-12-01
10885403517921BD AlarisCAREFUSION 303, INC.80152023-11-20
10885403517723BD AlarisCAREFUSION 303, INC.81002023-10-30
ENOU4161US0Dispenser DP 30 LipoPlusNouvag AG4161US2017-01-13
ENOU4163US0Dispenser DP 30 LipoPlusNouvag AG4163US2017-01-13
ENOU4180US0Dispenser DP 30Nouvag AG4180US2017-01-13
ENOU4181US0Dispenser DP 30 LipoPlusNouvag AG4181US2017-01-13
ENOU4186US0Dispenser DP 30Nouvag AG4186US2018-08-21
ENOU4187US0Dispenser DP 30Nouvag AG4187US2017-01-13
10885403516023BD Alaris™ PCU Module, Model 8015CAREFUSION 303, INC.80152023-09-18
27290109155146Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTD17000-031-10402023-09-05
17290109151288Sapphire M.T. Infusion Kit–EGNA USEITAN MEDICAL LTD17000-028-00722023-08-30