Duns Number:595138793
Catalog Number
688694/B
Brand Name
Meritrans DTXPlus®
Version/Model Number
10884450373009
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
7fbdaa13-d5d2-4250-94b5-0a215111b6df
Public Version Date
December 13, 2021
Public Version Number
2
DI Record Publish Date
February 25, 2020
Package DI Number
20884450373006
Quantity per Package
10
Contains DI Package
10884450373009
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 |