Duns Number:828611934
Catalog Number
-
Brand Name
Medex
Version/Model Number
MX90013
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 13, 2019
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
-
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
K951129
Product Code
DRS
Product Code Name
TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
Public Device Record Key
37ad4598-3148-4a8a-933e-0c8a3c0ba09e
Public Version Date
October 08, 2019
Public Version Number
5
DI Record Publish Date
October 13, 2016
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 |
---|---|---|
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 |