Duns Number:354059073
Device Description: Navina Transanal Irrigation. Consumable set cone. 1 Water container, 15 Rectal catheters c Navina Transanal Irrigation. Consumable set cone. 1 Water container, 15 Rectal catheters cone. Non Sterile device. Rx Only.
Catalog Number
6901640
Brand Name
Navina™Consumable Set Cone
Version/Model Number
69016
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
FCE
Product Code Name
Enema kit
Public Device Record Key
1afc99e3-fb58-4b4e-a0ce-60779d330416
Public Version Date
December 27, 2019
Public Version Number
1
DI Record Publish Date
December 19, 2019
Package DI Number
07392532243905
Quantity per Package
3
Contains DI Package
07392532243899
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CustomerPackaging
| 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 |