Duns Number:012789116
Device Description: 27GA, 6mm, 42" Single Lumen Safety Subcutaneous Tissue Infusion Set with Transparent dress 27GA, 6mm, 42" Single Lumen Safety Subcutaneous Tissue Infusion Set with Transparent dressing, Latex Free, Non-DEHP PVC tubing, Priming Volume Approx.: .15ml
Catalog Number
-
Brand Name
All-Med, Inc.
Version/Model Number
MC4206-SS
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
ed96e5de-0431-49cb-a4c7-8c426ed86067
Public Version Date
October 10, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10816339027031
Quantity per Package
50
Contains DI Package
10816339020049
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 |