Duns Number:080342917
Device Description: 6" Minibore Extension Set with Split Septum Micro T-Connector, Rotating Male Luer Lock & N 6" Minibore Extension Set with Split Septum Micro T-Connector, Rotating Male Luer Lock & Non-Removable Slide Clamp
Catalog Number
-
Brand Name
Split Septum Micro T-Connector
Version/Model Number
NMT8046
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"
Yes
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
f0e5b886-94ba-49cf-bc90-e9c2f154b5f0
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2016
Package DI Number
10850584007011
Quantity per Package
100
Contains DI Package
00850584007014
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |