Duns Number:192135242
Device Description: PMI Pharmacy pump set, straight with spike and luer lock distal end
Catalog Number
PMI9111
Brand Name
PMI
Version/Model Number
PMI9111
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
864a7b39-68f6-4b06-b937-fc2e6a809c5d
Public Version Date
March 13, 2020
Public Version Number
3
DI Record Publish Date
July 31, 2017
Package DI Number
00812608021505
Quantity per Package
10
Contains DI Package
00812608021338
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |