Duns Number:679894738
Device Description: Insufflation Tubing 10ft (3m) with 0.1-micron Hi-Flow Filter, Rotating Luer Lock Fitting,S Insufflation Tubing 10ft (3m) with 0.1-micron Hi-Flow Filter, Rotating Luer Lock Fitting,Sterile
Catalog Number
-
Brand Name
Alleset
Version/Model Number
Model C-2000-ST
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
7305cc10-eadb-4114-b9ec-697934239e9e
Public Version Date
February 12, 2021
Public Version Number
1
DI Record Publish Date
February 04, 2021
Package DI Number
26931918148417
Quantity per Package
25
Contains DI Package
16931918148410
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 |