Duns Number:249008772
Device Description: Ideal for quickly detecting elevated body temperature using a non-contact design. Measures 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).
Catalog Number
5700
Brand Name
I-MED Non-Contact Infrared digital Clinical Thermometer
Version/Model Number
5700
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FLL
Product Code Name
Thermometer, electronic, clinical
Public Device Record Key
cf5ac084-d8cf-4455-81de-c703fd63d45c
Public Version Date
October 05, 2022
Public Version Number
3
DI Record Publish Date
June 18, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |