Withdrawal/infusion Pump

Device Code: 2519

Product Code(s): DQI

Device Classification Information

Device Type ID2519
Device NameWithdrawal/infusion Pump
Regulation DescriptionWithdrawal-infusion Pump.
Regulation Medical SpecialtyCardiovascular
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type510(k)
CFR Regulation Number870.1800 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDQI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID2519
DeviceWithdrawal/infusion Pump
Product CodeDQI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionWithdrawal-infusion Pump.
CFR Regulation Number870.1800 [🔎]
TPLC Last Update: 2019-04-02 20:13:41

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