Duns Number:595138793
Catalog Number
682078/A
Brand Name
Merit Medical®
Version/Model Number
10884450325213
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
DRS
Product Code Name
Transducer, blood-pressure, extravascular
Public Device Record Key
d5d88597-ba90-4f79-9118-0fc035710ff9
Public Version Date
December 13, 2021
Public Version Number
2
DI Record Publish Date
July 17, 2019
Package DI Number
20884450325210
Quantity per Package
5
Contains DI Package
10884450325213
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 |