Duns Number:012789116
Device Description: 96" Extension Set with Male Luer Lock, Slide Clamp and Female Luer Lock. Lipid Resistant, 96" Extension Set with Male Luer Lock, Slide Clamp and Female Luer Lock. Lipid Resistant, Non-DEHP PVC tubing, Latex Free. Approximate Priming Volume: 1.5ml
Catalog Number
-
Brand Name
All-Med, Inc.
Version/Model Number
43-9604
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
4f8b826c-24a5-4c5c-99c2-c8bee61b8b13
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
10816339028380
Quantity per Package
50
Contains DI Package
10816339022425
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 |