Duns Number:595138793
Catalog Number
682034/B
Brand Name
Meritrans DTXPlus®
Version/Model Number
10884450385163
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
240a7c21-e4b9-4aaa-8fa3-91c9ff9391f1
Public Version Date
June 16, 2022
Public Version Number
1
DI Record Publish Date
June 08, 2022
Package DI Number
20884450385160
Quantity per Package
10
Contains DI Package
10884450385163
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 |