Duns Number:595138793
Catalog Number
682106/A
Brand Name
Merit Medical®
Version/Model Number
10884450325299
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
FPK
Product Code Name
Tubing, fluid delivery
Public Device Record Key
312bc29b-fad2-4043-9059-a14d3bd105ff
Public Version Date
November 19, 2018
Public Version Number
1
DI Record Publish Date
October 18, 2018
Package DI Number
20884450325296
Quantity per Package
5
Contains DI Package
10884450325299
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 |