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I-MED Non-Contact Infrared digital Clinical Thermometer
I-Med Pharma Inc · Model 5700 · UDI-DI 00622554057004
10
510(k) clearances
6
Adverse events
2
Recalls
46
Facilities
Description
Ideal for quickly detecting elevated body temperature using a non-contact design. Measures body temperature from 90°F to 109°F (32.0°C to 42.5°C) without contact. Accurate to 0.5°F (0.3°C) with 0.1°F/°C resolution. Adjustable alarm alerts user visually and audibly when temperature exceeds programmed limit. Optimum measurement distance of 2 in. to 5.9-in. (5 to 15 cm).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-10 | BearCare, Inc. | There have been reports of skin burns to children wearing the device. |
| 2013-07-10 | Medical Indicators, Inc. | TempaDot products may have been mislabeled. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.