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Temp,Daw,Recall,Devi
Class/Term | Define |
---|---|
Freezer Temperature | -25°C to 10°C or -13°F to 50°F |
Refrigerator Temperature | 2°C to 8°C or 35.6°F to 46.4°F |
Cool/Room Temperature | 20°C to 25°C or 68°F to 77°F |
DAW 0 | No product selected |
DAW 1 | No substitution allowed by prescriber |
DAW 2 | Substitution allowed, requested brand by patient |
DAW 3 | Substitution allowed, Pharmacist selects product |
DAW 4 | Substitution allowed, generic drug not in stock |
DAW 5 | Substitution allowed, brand name dispensed as generic |
DAW 6 | Override/Undefined |
DAW 7 | Substitution not allowed, brand mandated by law |
DAW 8 | Substitution allowed, generic now available in marketplace |
DAW 9 | Other/Undefined |
Class I Recall | Reasonable probability of serious adverse health consequences or death |
Class II Recall | May cause temporary or reversible advers health consequences, remote probability of serious adverse health consequences |
Class III Recall | Not likely to cause adverse health consequences |
Market Withdrawal | Minor violation that would not be subject to FDA legal action. Company remove product from market or corrects violation. |
Medical Device Safety Alert | Device may present unreasonable risk of substantial harm. In some cases could also be considered recalls |
Medical Device Class I | Minimal Risk. Ex. Bandages, surgical instruments |
Medical Device Class II | Moderate to high risk. Ex. Used to diagnose, treat or cure patients |
Medical Device Class III | High risk or injury or illness. Ex. Used to support life |