Duns Number:003530786
Device Description: The Truer Medical Skin Temperature Sensor is designed for monitoringa patient’s skin surfa The Truer Medical Skin Temperature Sensor is designed for monitoringa patient’s skin surface temperature during surgical procedures,postoperative recovery, or whenever a clinician needs to accuratelyassess patient skin temperature. The Truer Medical, Inc. Skin Sensorhas reflective silver material on one side to insulate the sensor fromheat generated by operating room lights or heat lamps.
Catalog Number
SSP 400
Brand Name
Truer Medical, Inc.
Version/Model Number
SSP 400
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101244,K101244,K101244,K101244,K101244,K101244,K101244
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
e0d3c110-8e35-421f-9f93-75a7412dd03d
Public Version Date
December 04, 2020
Public Version Number
4
DI Record Publish Date
August 04, 2016
Package DI Number
40859290006135
Quantity per Package
26
Contains DI Package
10859290006134
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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. | 2 |