Duns Number:965627859
Device Description: Insufflation Tubing Set with Filter and Dual Luer Locks
Catalog Number
-
Brand Name
JosNoe Medical Inc
Version/Model Number
PFITF-10
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
NKC
Product Code Name
Tubing/Tubing With Filter, Insufflation, Laparoscopic
Public Device Record Key
64563a63-8786-4ca2-a896-23ad00608cb6
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 11, 2019
Package DI Number
00850003294124
Quantity per Package
10
Contains DI Package
00850003294070
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 15 |