Duns Number:207372814
Device Description: Accurate readings in as little as 10 seconds. •Accurate within 0.2 °F / 0.1 °C•Use or Accurate readings in as little as 10 seconds. •Accurate within 0.2 °F / 0.1 °C•Use orally, rectally or underarm•Fast 10 second reading•Beep signals peak temperature•Water resistant for easy cleaning•Automatic shut-off feature
Catalog Number
016-644
Brand Name
Physio Logic Digital 10 Thermometer
Version/Model Number
016-644
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)
-
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
57a3c558-3d41-4d1a-b726-435238e6be9b
Public Version Date
August 21, 2020
Public Version Number
3
DI Record Publish Date
May 16, 2018
Package DI Number
05756597054586
Quantity per Package
24
Contains DI Package
05756597053800
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |