Duns Number:012789116
Device Description: 36" Ultra Mini Bore extension set with Male Luer Lock and Female luer lock. Lipid Resista 36" Ultra Mini Bore extension set with Male Luer Lock and Female luer lock. Lipid Resistant, Latex Free, Non-DEHP PVC tubing. Approximate Priming Volume: 0.18ml
Catalog Number
-
Brand Name
All-Med, Inc.
Version/Model Number
40-3600
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
0716359f-68dc-4487-967b-b392eaf3c437
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
10816339028151
Quantity per Package
50
Contains DI Package
10816339022197
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 |