Duns Number:008314390
Device Description: The web based application for calculating pediatric urea hydrolysis rate as part of the Br The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.
Catalog Number
-
Brand Name
Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA
Version/Model Number
2.0
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P100025
Product Code
OZA
Product Code Name
Test, Urea Adult And Pediatric (Breath),
Public Device Record Key
d2a5eb26-05ae-44d1-9c97-87beddaadc26
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 19, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |
| 3 | A medical device with high risk that requires premarket approval | 2 |