Duns Number:828611934
Catalog Number
-
Brand Name
Medex
Version/Model Number
MX20885R1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 23, 2020
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"
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
DRS
Product Code Name
TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
Public Device Record Key
724bcaf5-52e5-4b0d-9c95-59e7616de356
Public Version Date
October 23, 2020
Public Version Number
5
DI Record Publish Date
December 30, 2016
Package DI Number
50351688508612
Quantity per Package
10
Contains DI Package
10351688508614
Package Discontinue Date
October 23, 2020
Package Status
Not in Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 104 |
2 | A medical device with a moderate to high risk that requires special controls. | 36112 |