Duns Number:023287700
Device Description: The interface module is a stationary electronic component of the Heidelberg pH capsule tel The interface module is a stationary electronic component of the Heidelberg pH capsule telemetric monitoring system designed to continuously monitor incoming date from the Heidelberg transceiver. The interface transmits the incoming pH data and events from the transceiver and assigns a specific channel to the data and routes it to the computer for display on one to eight graphs.
Catalog Number
HMI118
Brand Name
Heidelberg pH Capsule System
Version/Model Number
Heidelberg Interface Module
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
94a592b4-1624-4eb3-aa78-288ac670af29
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 |