Duns Number:023287700
Device Description: The cart (trolley) is a Non-Metallic 3 shelf mobile equipment cart, is used for transporti The cart (trolley) is a Non-Metallic 3 shelf mobile equipment cart, is used for transporting the Heidelberg pH Capsule systems devices.
Catalog Number
EC115
Brand Name
Heidelberg pH Capsule System
Version/Model Number
Heidelberg System Equipment Cart
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)
-
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
2ca7c3b6-94fb-453d-b526-8416dd3e3f9c
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 |