BEUDAMED
    3 results · 12ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I ×

    Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·January 25, 2017

    Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 362033 UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; 362034 Priming volume: 19mL, length: 120in, SafeLine; 362035 INFUSOMAT SPACE PUMP IV SET; 362043 Priming volume: 39mL, length: 120in, SafeLine; 362050 15 drops/mL, priming volume: 26mL, length: 124in, SafeLine; 362420 SPACE PUMP SET 15 DROP W/2 SAFEDAY; 362432 15 drops/mL, priming volume: 21mL, length: 118in, ULTRASITE; 362911 Priming volume: 14mL, length: 84in, CARESITE, Spin-Lock; 363010 Priming volume: 21mL, length: 121in, SafeLine; 363019 Priming volume: 40mL, length: 123in, SafeLine; 363030 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 363032 20 drops/mL, priming volume: 20mL, length: 119in, SafeLine; 363230 15 drops/mL, priming volume: 22mL, length: 123in, ULTRASITE; 363410 15 drops/mL, priming volume: 23mL, length: 119in, CARESITE; 363419 Priming volume: 41mL, length: 120in, CARESITE; 363420 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; 363421 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 363422 Priming volume: 21mL, length: 130in, CARESITE; 363423 60 drops/mL, priming volume: 21mL, length: 118in, CARESITE; 363424 UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; 363430 15 drops/mL, priming volume: 23mL, length: 123in, CARESITE; 363433 UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; 363901 60 drops/mL, priming volume: 11mL, length: 129in; 363902 Priming volume: 25mL, length: 130in; 363904 UNIV. 15 DROP PUMP SET, ASV; 470119 15 drops/mL, priming volume: 23mL, length: 119in, CARESITE; 480254 SPACE PUMP IV SET 15D, 110 IN.; 480255 SPACE PUMP IV SET, 127 IN; 480257 60 DROP NITRO SPACE SET, 88 IN.; 480258 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER; 480263 SPACE PUMP IV SET 15D, 90 IN.; 480264 SPACE PUMP IV SET, 15 DRPS/ML, 95 IN.; 490037 Priming volume: 25mL, length: 136in; 490038 60 drops/mL, priming volume: 11mL, length: 129in; 490100 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 490101 Priming volume: 19mL, length: 120in, CARESITE; 490102 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 490103 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; 490104 60 drops/mL, priming volume: 21mL, length: 115in, CARESITE; 490105 Priming volume: 39mL, length: 120in, CARESITE

    FDA Enforcement
    Class I ·Ongoing·B. Braun Medical, Inc.·December 13, 2023

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024