Duns Number:439770017
Device Description: The patient cable, ST-PTCBL is the component of SENSITHERM MULTI System which connects the The patient cable, ST-PTCBL is the component of SENSITHERM MULTI System which connects the main unit to the disposable temperature probe ST-PROBE. The handle at one end of the cable contains both the electronic circuits which digitize the temperatures and the components that make SENSITHERM MULTI System immune to the effects of a defibrillator discharge and other EMC disturbances. An contact custom socket on one side of the handle allows the user to connect the ST-PTCBL to a mapping system using the cable ST-ADPT-30.
Catalog Number
ST-PTCBL
Brand Name
SENSITHERM MULTI
Version/Model Number
ST-PTCBL
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192210
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
1cc43fa3-65f6-4c16-bd27-ee5e516fd31b
Public Version Date
February 14, 2022
Public Version Number
1
DI Record Publish Date
February 04, 2022
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. | 42 |