Duns Number:023287700
Device Description: The pH Capsule Calibration Kit is designed primarily for activating and calibrating the pH The pH Capsule Calibration Kit is designed primarily for activating and calibrating the pH telemetric capsule, it includes the following: the calibration test fixture is a 10-inch square acrylic plate that contains a raised capsule holder for holding the pH capsule during calibration. The acrylic plate also has a clear acrylic block attached to it, for holding 6 test tubes. There are two large round holes in the sides of the plate: for holding the Saline and Rinse contains. There is also provision for placement of the glass Alkaline challenge container. Included with the Kit is a glass container labeled Saline, a glass container labeled Rinse and a glass container labeled NaCH03. The kit contains 6 test tubes, one spool of tether thread, solutions, a 6-inch Delrin capsule holder: for holding the pH capsule during the pH calibration procedure.
Catalog Number
PCCK330
Brand Name
Heidelberg pH Capsule System
Version/Model Number
Heidelberg pH Capsule Calibration Kit
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
96d246e2-af9c-4b9c-baeb-3ccc28f83fbc
Public Version Date
November 23, 2020
Public Version Number
1
DI Record Publish Date
November 13, 2020
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 | 7 |