FDA.reportPublic FDA data

Patient-controlled analgesia infusion pump

Definition
A battery-powered infusion device designed to deliver intermittent bolus doses of opioid medications [e.g., Fentanyl, Demerol (meperidine), Morphine, or Hydromorphone] upon patient demand (i.e., when activated by the patient when he/she requires pain relief), or in a slow, continuous mode for regional anaesthesia. A patient-controlled analgesia (PCA) infusion pump is used to infuse drugs into an operative site, or subcutaneously for postoperative pain management. It is used for hospital/home-use and can be worn by the patient for ambulation. It will incorporate safety mechanisms to prevent the patient overdosing; some types will employ computerized ambulatory drug delivery (CADD) software.
GUDID devices
27
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00817170020086Nimbus II PainPROINFUTRONIX LLCNimbus II PainPRO2017-05-22
00817170020093Nimbus II FlexINFUTRONIX LLCNimbus II Flex2017-07-05
00817170020109NimbusINFUTRONIX LLCNimbus II EMS2017-08-31
00817170020161Nimbus II PlusINFUTRONIX LLCNimbus II Plus2019-03-06
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.Curlin Pump2021-04-29
M3352083704021Lifecare PCAICU MEDICAL, INC.2083704022018-12-13
M745BC10747AIVAMERICAN IV PRODUCTS, INC.BC107472016-09-02
M745BC10925AIVAMERICAN IV PRODUCTS, INC.BC109252016-09-02
M3352070904871Lifecare PCAICU Medical, Inc.207092017-10-04
M3352083704011Lifecare PCAICU Medical, Inc.208372017-10-04
10885403812002AlarisCAREFUSION 303, INC.81202016-12-08
10814844001010CurlinZEVEX INTERNATIONAL, INC.Curlin Bolus Cord2021-11-03
10885403812026AlarisCAREFUSION 303, INC.81202021-11-01
10885403812033AlarisCAREFUSION 303, INC.81202021-10-08
10885403494291AlarisCAREFUSION 303, INC.81202021-09-29
30814844000376Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.Curlin Pump2021-04-29
00817170020376Nimbus II EpiDINFUTRONIX LLCNimbus II EpiD2020-09-02
20817170020165Nimbus II PlusINFUTRONIX LLCNimbus II Plus2019-03-06
M745BC10746AIVAMERICAN IV PRODUCTS, INC.BC107462016-09-02
M745BC10969AIVAMERICAN IV PRODUCTS, INC.BC109692016-09-02
18148440000361Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.Curlin Pump2016-10-21
18148440001016CurlinZEVEX INTERNATIONAL, INC.12018-08-03
00817170020154NimbusINFUTRONIX LLCNimbus Hard Shell 100ml2019-01-15
10817170020007NimbusINFUTRONIX LLCNimbus2016-09-23
10817170020083Nimbus II PainPROINFUTRONIX LLCNimbus II PainPRO2017-05-22
10817170020090Nimbus II FlexINFUTRONIX LLCNimbus II Flex2017-07-05
10817170020106NimbusINFUTRONIX LLCNimbus II EMS2017-08-31