Duns Number:595138793
Catalog Number
682108/A
Brand Name
Merit Medical®
Version/Model Number
10884450325312
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
aea4e430-9acd-46ab-98d8-f48cb5ace577
Public Version Date
April 13, 2021
Public Version Number
1
DI Record Publish Date
April 05, 2021
Package DI Number
20884450325319
Quantity per Package
5
Contains DI Package
10884450325312
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 |