Duns Number:044611812
Device Description: Winged Infusion Set 25G x 0.75 inch with y-site
Catalog Number
0603340
Brand Name
Port Access Needle
Version/Model Number
0603340
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
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
48d02e53-60c8-4a80-aaa7-7f9a14c4cd69
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
20801741065792
Quantity per Package
12
Contains DI Package
10801741065795
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
| U | Unclassified | 8 |