Duns Number:192135242
Device Description: Bifurcated Pharmacy Fluid Transfer Set with Universal Spike, Silicone Pump Insert with Bri Bifurcated Pharmacy Fluid Transfer Set with Universal Spike, Silicone Pump Insert with Bridge, Male Luer
Catalog Number
PMIX02
Brand Name
PMI
Version/Model Number
PMIX02
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
e5e63e7f-d6a5-4145-9016-ca37aace9e99
Public Version Date
March 26, 2019
Public Version Number
1
DI Record Publish Date
March 18, 2019
Package DI Number
00812608022038
Quantity per Package
5
Contains DI Package
00812608021994
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |