Duns Number:192135242
Device Description: PMI Empty IV Bag 150 mL; 2 ports
Catalog Number
PMI150ML
Brand Name
PMI
Version/Model Number
PMI150ML
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
KPE
Product Code Name
Container, I.V.
Public Device Record Key
ccbc5353-ff97-4e1d-9708-5307a4e47005
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
May 01, 2018
Package DI Number
10812608021724
Quantity per Package
6
Contains DI Package
00812608021727
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 |