Duns Number:679894738
Device Description: Insufflation Tubing 12ft(3.7m) with 0.1-micron Hi-Flow Filter_Rotating Luer Lock Fitting_N Insufflation Tubing 12ft(3.7m) with 0.1-micron Hi-Flow Filter_Rotating Luer Lock Fitting_NS_100ea/cs
Catalog Number
-
Brand Name
Alleset
Version/Model Number
Model C-2012-NS
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NKC
Product Code Name
Tubing/tubing with filter, insufflation, laparoscopic
Public Device Record Key
022915ed-1ee3-4df9-88c4-678015ce3a77
Public Version Date
March 16, 2021
Public Version Number
1
DI Record Publish Date
March 08, 2021
Package DI Number
26931918141159
Quantity per Package
2
Contains DI Package
16931918141152
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 185 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 295 |