Duns Number:003530786
Device Description: Truer Medical General Purpose Probes are designed for continuoustemperature monitoring. Pr Truer Medical General Purpose Probes are designed for continuoustemperature monitoring. Probes can be introduced through oralor rectal openings. Probes tips have special low-friction“frosted” finish to aid in the ease of placement and patient comfort.
Catalog Number
GP 9400
Brand Name
Truer Medical, Inc.
Version/Model Number
GP 9400
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
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
b9e99d6b-309e-42c4-82a7-d7cc4a553fa1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 06, 2016
Package DI Number
40859290006111
Quantity per Package
6
Contains DI Package
20859290006117
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 |