Duns Number:090073722
Device Description: Disposable pH / Impedance Catheter, Dual pH Sensor, 25cm, 8 Impedance Rings, LPR ZNID25+8R
Catalog Number
-
Brand Name
Versaflex
Version/Model Number
FGS-9000-20
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
-
Product Code
FFT
Product Code Name
Electrode, pH, stomach
Public Device Record Key
9fde9b0f-5f74-48a0-928a-2f0c7ef4e828
Public Version Date
October 03, 2022
Public Version Number
3
DI Record Publish Date
August 29, 2018
Package DI Number
04260167483436
Quantity per Package
10
Contains DI Package
04260167484136
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |