Duns Number:012789116
Device Description: 27ga, 9mm, 36" Quad-furcated Safety Subcutaneous Tissue Infusion Set with Transparent dres 27ga, 9mm, 36" Quad-furcated Safety Subcutaneous Tissue Infusion Set with Transparent dressing, Latex Free, Non-DEHP PVC tubing, Priming Volume Approx.: 0.80ml
Catalog Number
-
Brand Name
All-Med, Inc.
Version/Model Number
MCQU3609-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
e3636760-83f7-47b0-b1c9-8402ba7f865a
Public Version Date
October 10, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10816339027246
Quantity per Package
10
Contains DI Package
10816339020254
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 |