Duns Number:012789116
Device Description: 27ga, 9mm, 18" Single Lumen Safety Subcutaneous Tissue Infusion Set with transparent dress 27ga, 9mm, 18" 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
MC1809-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
b67ca867-68cd-4704-b642-3d390e5edf90
Public Version Date
October 10, 2022
Public Version Number
3
DI Record Publish Date
August 04, 2017
Package DI Number
50816339022577
Quantity per Package
50
Contains DI Package
10816339022579
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 |