Duns Number:090073722
Device Description: Disposable pH Catheter, Single Sensor, LES Locator, VIIS
Catalog Number
957980
Brand Name
Versaflex
Version/Model Number
957980
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"
-
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
-
Product Code
FFT
Product Code Name
Electrode, pH, stomach
Public Device Record Key
e0e806de-2928-4178-a22d-3d32850c7320
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
August 29, 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 | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |