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Model Number 10D. Device Problem No Information. Event Type Injury. Event Description. Manufacturer Narrative. This report is in response to fda letter (b)(4) in Is this clearly stated in the instructions for use? the instructions for use contain the following information regarding temperature range, frequency of use and
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20 Aug 2015
INSTRUCTIONS. Cover pump with water, at least 2" above the pump itself. 2. Instead of loose ice-cubes, use ziplock bags of ice, or use. “Blue-ice" blocks, as used in picnic coolers. Or. Take empty 20 oz. pop bottles, fill with water and freeze. Use 2-3 at a time, in the cooler. When the ice has thawed, replace with frozen ones.
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