Duns Number:185719606
Device Description: A small capsule shaped sensor which contains an electronic thermometer. The sensor operate A small capsule shaped sensor which contains an electronic thermometer. The sensor operates at 262 kHz frequency and transmits via near field magnetic link.
Catalog Number
-
Brand Name
CorTemp
Version/Model Number
HT150002
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K880639
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
f99fa2c1-4e38-4eab-ac5b-5d1c41be0a87
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 28, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |