Duns Number:338430324
Device Description: THD PressKit is a practical and completely disposable kit composed of a probe (THD PRessPr
Catalog Number
800142
Brand Name
THD PressKit
Version/Model Number
THD PressKit (TR BOX)
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
K161785,K161785,K161785,K161785
Product Code
KLA
Product Code Name
Monitor, Esophageal Motility, And Tube
Public Device Record Key
6d1ec9a9-a9ba-400c-97e4-d2d3eefa6c41
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
September 20, 2017
Package DI Number
28033737711266
Quantity per Package
5
Contains DI Package
08033737711262
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cartoon Box
| 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 |