5a466261-3b5a-44e4-ac51-9f47eba9373fUpdatePublished72024-04-032014-09-202023-07-28Not in Commercial Distribution20886704043741PackageGS11088670404374452023-07-28Not in Commercial DistributionCase10886704043744PrimaryGS1NAAP-04032-5AP040325482661753Medos International Sàrl1Special Bolus Needle for use with CODMAN 3000 series Drug Delivery System Straight Length 2inch (5 cm)falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationfalsefalse+1(800)255-2500xx@xx.xxP890055010P89005502134071Implantable intrathecal infusion pump, nonprogrammableA battery-powered nonprogrammable device designed to be implanted in a patient for the storing and subarachnoid administration of narcotics/drugs (e.g., morphine sulfate, baclofen) to manage intractable pain and muscle spasms of malignant or non-malignant origin. This implantable infusion pump (IIP) may enable delivery of a bolus of medication, typically patient-controlled with mechanical restrictions that limit the refill rate of the device, or it may provide a constant flow of medication at a factory-set rate. The device typically consists of a refillable drug reservoir, usually implanted under the skin of the lower abdomen, and a connected catheter placed into the spinal fluid space.trueActiveLKKPUMP, INFUSION, IMPLANTED, PROGRAMMABLEHandling Environment TemperatureStorage Environment TemperatureStorage Environment TemperatureHandling Environment TemperatureSpecial Storage Condition, SpecifyDo not use if opened or damaged.truefalse