Duns Number:207372814
Device Description: This thermometer's innovative design offers 2 convenient and accurate ways to measure body This thermometer's innovative design offers 2 convenient and accurate ways to measure body temperature instantly.The Insta-Therm Quick-Scan’s innovative infrared technology allows probe-free scanning from either the ear or forehead. Requires no probe covers! Innovative design allows for choice of 2 body temperature measuring options: Ear and Forehead. Memory stores last 10 readings.
Catalog Number
-
Brand Name
Physiologic Insta-Therm Quick-Scan Thermometer
Version/Model Number
016-670
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
e9fc993d-598e-412f-ab7c-a12c055730e4
Public Version Date
December 04, 2020
Public Version Number
5
DI Record Publish Date
January 05, 2017
Package DI Number
05756598834224
Quantity per Package
10
Contains DI Package
05756598833548
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |