Duns Number:184763290
Catalog Number
PIB1000/A
Brand Name
Merit Medical®
Version/Model Number
00884450011911
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
KZD
Product Code Name
INFUSOR, PRESSURE, FOR I.V. BAGS
Public Device Record Key
dbbbeb3d-af47-41a6-94cc-015d375a89ea
Public Version Date
November 19, 2020
Public Version Number
3
DI Record Publish Date
February 16, 2018
Package DI Number
10884450011918
Quantity per Package
12
Contains DI Package
00884450011911
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 |