Duns Number:207372814
Device Description: 3 in 1 Thermometer: Body, Room, Liquids and surfacesNon-contact infrared probeProfessional 3 in 1 Thermometer: Body, Room, Liquids and surfacesNon-contact infrared probeProfessional AccuracyFaster and more precise than an ear thermometerNon-Contact up to 1- 2" (3 cm - 5 cm) distance from forehead. This means a greatly reduced risk of contagion, without the need for probe covers.Back-lit screen with colour-coded fever alert: green for normal, orange for a low fever and red for a fever of or above 38 C (100.4 F).Fully programmable alerts can be set to detect fever for a specific age group or illness.Use it to ensure that food temperature is safe before serving.Prevent scalding due to hot bath water.Audio alert signals peak temperature and fever.Voice feature can assist users with impaired vision and can be set to English, French, Spanish or mute.Keeps the last 32 temperature readings in memory.Displays in C or F.Auto shut-off for extended battery life.Longevity: 40,000 readings.2 alkaline AA batteries included.
Catalog Number
-
Brand Name
ProScan Non-Contact Infrared Thermometer by Physio Logic
Version/Model Number
016-660
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"
-
For Single-Use
-
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
47f890f7-845e-42b7-ad6f-7808fd64566c
Public Version Date
December 04, 2020
Public Version Number
5
DI Record Publish Date
March 04, 2020
Package DI Number
00057565942641
Quantity per Package
1
Contains DI Package
00057565166603
Package Discontinue Date
March 11, 2020
Package Status
Not in Commercial Distribution
Package Type
Retail
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |