FDA.reportPublic FDA data

General-purpose infusion pump, battery-powered

Definition
A battery-powered ambulatory device intended to provide continuous or intermittent administration of non-specific drugs and/or solutions. It consists of a small unit with a pumping mechanism and an infusion-rate controller, and is used with a dedicated single-use medication cartridge (not included). It is used with a suitable injection/infusion set for delivery via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt or carried in a pocket and may be used in a healthcare setting or in the home.
GUDID devices
34
Last updated
2022-02-15 08:10:33

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00193494000677ambIT* PreSet* Pump (packaged)Avanos Medical, Inc.2204262022-02-07
00193494000707ambIT* PIB-PCA PumpAvanos Medical, Inc.2205012022-02-07
00193494000769ambIT* PIB*IL PumpAvanos Medical, Inc.2205272022-02-07
00193494000813ambIT* PCA PumpAvanos Medical, Inc.2202622022-02-07
00193494000998ambIT* Military PCA PumpAvanos Medical, Inc.2204372022-02-07
00193494001049ambIT* Continuous PumpAvanos Medical, Inc.2202442022-02-07
00193494001216ambIT* KIDS PIB Pump-BlueAvanos Medical, Inc.2205402022-02-07
00193494001384ambIT* PIB IL v 1.5Avanos Medical, Inc.2205712022-02-07
00850017421042RemunityUnited Therapeutics CorporationDKPI-11038-0012021-02-11
00850017421097RemunityUnited Therapeutics CorporationDKPI-21128-0012021-02-11
00850017421035RemunityUnited Therapeutics CorporationDKPI-11042-0012020-12-11
00850017421073RemunityUnited Therapeutics CorporationDKPI-11036-0012020-12-11
00862492000308Zyno SolutionsOPTUMHEALTH CARE SOLUTIONS, INC.Pump Nimbus II Plus2020-12-07
00850000509078ambITSUMMIT MEDICAL PRODUCTS, INC.2205712020-08-17
08624920003099CMEOPTUMHEALTH CARE SOLUTIONS, INC.Pump T34OB2020-05-26
00857595005923ambIT SUMMIT MEDICAL PRODUCTS, INC.2205402020-05-06
00850000509023ambITSUMMIT MEDICAL PRODUCTS, INC.2205462020-04-23
00850000509030ambITSUMMIT MEDICAL PRODUCTS, INC.2205722020-04-23
B101100100POBSC0T34 Syringe Pump SystemCME AMERICA LLC100-100POBSC2016-09-15
B101100100PSA0T34 Syringe Pump SystemCME AMERICA LLC100-100PSA2016-09-15
00857595005572ambITSUMMIT MEDICAL PRODUCTS, INC.2202442016-09-09
00857595005589ambITSUMMIT MEDICAL PRODUCTS, INC.2202622016-09-09
00857595005596ambITSUMMIT MEDICAL PRODUCTS, INC.2203262016-09-09
00857595005602ambITSUMMIT MEDICAL PRODUCTS, INC.2204262016-09-09
00857595005619ambITSUMMIT MEDICAL PRODUCTS, INC.2204522016-09-09
00857595005626ambITSUMMIT MEDICAL PRODUCTS, INC.2204612016-09-09
00857595005640ambITSUMMIT MEDICAL PRODUCTS, INC.2204682016-09-09
00857595005664ambITSUMMIT MEDICAL PRODUCTS, INC.2204762016-09-09
00857595005671ambITSUMMIT MEDICAL PRODUCTS, INC.2204372016-09-09
00857595005688ambITSUMMIT MEDICAL PRODUCTS, INC.2205012017-12-18
00857595005695ambITSUMMIT MEDICAL PRODUCTS, INC.220501Y2018-02-27
00857595005817ambITSUMMIT MEDICAL PRODUCTS, INC.2205342018-07-16
00857595005824ambIT SUMMIT MEDICAL PRODUCTS, INC.2205272018-06-21
00859695006077WalkMed®WALKMED TECHNOLOGIES, LLC2046092016-09-24