Duns Number:030650113
Device Description: Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal)
Catalog Number
ZPN-BG-57
Brand Name
Diversatek Healthcare
Version/Model Number
ZPN-BG-57
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
FFX
Product Code Name
System, Gastrointestinal Motility (Electrical)
Public Device Record Key
3e356cb4-9a8b-4fac-b8ef-57e3ed8218b1
Public Version Date
October 19, 2020
Public Version Number
2
DI Record Publish Date
October 02, 2019
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 | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 207 |