Duns Number:185719606
Device Description: Lease Handheld electronic device which receives temperature sensitive crystal oscillation Lease Handheld electronic device which receives temperature sensitive crystal oscillations via near field magnetic link. The oscillation measurement is converted to a temperature using the sensor's calibration number.
Catalog Number
-
Brand Name
CorTemp
Version/Model Number
HT150001L
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
-
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
0290d365-ff6f-4c33-910b-2d92ecc44fd5
Public Version Date
April 10, 2019
Public Version Number
1
DI Record Publish Date
April 02, 2019
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 |