Duns Number:595138793
Catalog Number
682007/B
Brand Name
Meritrans DTXPlus®
Version/Model Number
10884450371753
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
Yes
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
DXN
Product Code Name
System, measurement, blood-pressure, non-invasive
Public Device Record Key
4aa68db4-46e9-4330-b5b9-81435f723e32
Public Version Date
December 13, 2021
Public Version Number
2
DI Record Publish Date
October 11, 2019
Package DI Number
20884450371750
Quantity per Package
5
Contains DI Package
10884450371753
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 392 |