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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 |
Created by:
Tannabanana
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