Duns Number:012789116
Device Description: 20ga x .75" Non-coring Winged Administration Set with Y Injection Site, 9" Non-DEHP PVC tu 20ga x .75" Non-coring Winged Administration Set with Y Injection Site, 9" Non-DEHP PVC tubing with Pinch Clamp and Female Luer Lock, Latex Free, Lipid Resistant, Approx. Priming Volume: 0.35ml
Catalog Number
-
Brand Name
All-Med, Inc.
Version/Model Number
50-2022
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
749779c3-8043-4972-bbb2-b895f8b6be67
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10816339027567
Quantity per Package
12
Contains DI Package
10816339021152
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |