Duns Number:192135242
Device Description: PMI IV admin set with flow regulator and needle-free y-site approx. 11" from distal end, 1 PMI IV admin set with flow regulator and needle-free y-site approx. 11" from distal end, 100" length, 20 drop, 15 micron filter in drip chamber, rotating male luer lock, vented cap, pinch clamp
Catalog Number
PMIFR200
Brand Name
PMI
Version/Model Number
PMIFR200
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
34aa2d82-2523-423d-8147-c45b95b156af
Public Version Date
July 02, 2018
Public Version Number
1
DI Record Publish Date
May 31, 2018
Package DI Number
00812608021840
Quantity per Package
50
Contains DI Package
00812608021833
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 |