Duns Number:080411091
Device Description: The ProFusion Needle is a stainless-steel needle with a trocar tip and distal sideports fo The ProFusion Needle is a stainless-steel needle with a trocar tip and distal sideports for infusion. The device also consists of a proximal plastic hub for Luer lock connections.
Catalog Number
G58474
Brand Name
ProFusion Therapeutic Infusion Needle
Version/Model Number
PTIN-21-20.0
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"
-
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
GAA
Product Code Name
Needle, Aspiration And Injection, Disposable
Public Device Record Key
2bec358b-0ea8-403e-8c48-57dca505bd90
Public Version Date
March 12, 2021
Public Version Number
1
DI Record Publish Date
March 04, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |