Duns Number:354059073
Device Description: Navina Transanal Irrigation. Tube set. 1 Water container tube, 1 Rectal catheter tube. No Navina Transanal Irrigation. Tube set. 1 Water container tube, 1 Rectal catheter tube. Non Sterile Device. Rx Only.
Catalog Number
6901140
Brand Name
Navina™ Tube set
Version/Model Number
69011
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
-
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
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
475deac8-7679-4171-b9b9-e66250086da9
Public Version Date
April 13, 2020
Public Version Number
4
DI Record Publish Date
November 10, 2017
Package DI Number
07392532198502
Quantity per Package
3
Contains DI Package
07392532198496
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Customer pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |