Duns Number:354059073
Device Description: Navina Transanal Irrigation. Rectal Catheter set regular. 10 Rectal catheters regular. Sin Navina Transanal Irrigation. Rectal Catheter set regular. 10 Rectal catheters regular. Single use. Non sterile Device. Rx Only.
Catalog Number
6894040
Brand Name
Navina™ Rectal Catheter set regular
Version/Model Number
68940
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
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
442bef80-a0a2-4ab1-9b8b-9ed342d4694b
Public Version Date
April 13, 2020
Public Version Number
4
DI Record Publish Date
November 10, 2017
Package DI Number
07392532198380
Quantity per Package
30
Contains DI Package
07392532198373
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Transport packaging
| 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 |