Duns Number:184763290
Catalog Number
HPF301E/B
Brand Name
Merit Medical®
Version/Model Number
00884450567074
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
DXJ
Product Code Name
DISPLAY, CATHODE-RAY TUBE, MEDICAL
Public Device Record Key
ca4d7ec6-dfc5-44ab-8dac-8618ae5116ce
Public Version Date
November 23, 2021
Public Version Number
1
DI Record Publish Date
November 15, 2021
Package DI Number
20884450567078
Quantity per Package
4
Contains DI Package
10884450567071
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 573 |
2 | A medical device with a moderate to high risk that requires special controls. | 8779 |