Duns Number:192135242
Device Description: Pharmacy Fluid Transfer Set with universal Spike, Silicone Pump Insert with Bridge, Male L Pharmacy Fluid Transfer Set with universal Spike, Silicone Pump Insert with Bridge, Male Luer
Catalog Number
PMIX01
Brand Name
PMI
Version/Model Number
PMIX01
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
b697da92-237e-4ff7-bc93-54d763dc017d
Public Version Date
March 26, 2019
Public Version Number
1
DI Record Publish Date
March 18, 2019
Package DI Number
00812608021970
Quantity per Package
10
Contains DI Package
00812608021963
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 |