Duns Number:080378236
Device Description: Bundle of two thermometers:OCCOscan - The Non-contact Infrared Thermometer uses infrared s Bundle of two thermometers:OCCOscan - The Non-contact Infrared Thermometer uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object and the infrared sensor can recognize it to transfer to the proper electronic signal. The electronic signal can be processed in the subject device to convert to the temperature reading. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits.OCCOflex - Digital Thermometer enables fast and reliable measurements. These thermometers provide very high clinical accuracy and have been designed to provide maximum user-friendliness. Digital Thermometer series can be used in conjunction with or without a disposable probe cover when preferred. The basic principle of these thermometers is that a change of thermistor resistance, caused by changes in temperature, is converted to changes of frequency of R-C oscillator circuit. Therefore, the temperature can be given by measuring the frequency of the oscillator. For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.
Catalog Number
-
Brand Name
OCCObaby
Version/Model Number
OCCOscan OCCOflex Bundle
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 30, 2020
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
ed73ec66-0d8a-4980-97ce-0220eafde4b1
Public Version Date
October 18, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
10863101000327
Quantity per Package
50
Contains DI Package
00863101000320
Package Discontinue Date
April 30, 2020
Package Status
Not in Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |