Duns Number:192135242
Device Description: PMI Straight Huber Needle w/Female Luer Connector 22G x 1 ½"
Catalog Number
PMIS2215
Brand Name
PMI
Version/Model Number
PMIS2215
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
91ba73b1-634c-453f-bb2d-4081454fc4ef
Public Version Date
April 04, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
10812608020031
Quantity per Package
12
Contains DI Package
00812608020034
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 |