Duns Number:007941230
Device Description: Tubing Insufflation 0.1 Micron Filter Quick-Connect DEHP-Free Polyvinyl Chloride 10 Feet N Tubing Insufflation 0.1 Micron Filter Quick-Connect DEHP-Free Polyvinyl Chloride 10 Feet Non-Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
INSF02NS
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
NKC
Product Code Name
Tubing/tubing with filter, insufflation, laparoscopic
Public Device Record Key
daaa4fd3-2bab-4802-accc-87827772f9de
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 23, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |