Duns Number:338430324
Device Description: THD SensyProbe Accessory consists of a syringe and a 3-way stopcock. The syringe is provid THD SensyProbe Accessory consists of a syringe and a 3-way stopcock. The syringe is provided with a male luer lock that allows the connection to the THD SensyProbe inflation line.
Catalog Number
750032
Brand Name
THD SensyProbe
Version/Model Number
THD SensyProbe Accessory
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"
Yes
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
K180135
Product Code
KLA
Product Code Name
Monitor, Esophageal Motility, And Tube
Public Device Record Key
2feed46c-9440-4cc6-84e6-3564ed60ffe3
Public Version Date
August 05, 2022
Public Version Number
3
DI Record Publish Date
March 20, 2018
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |