Duns Number:354059073
Device Description: Navina Smart Transanal Irrigation. 1 Navina Smart control unit, 1 Water container, 1 Tube Navina Smart Transanal Irrigation. 1 Navina Smart control unit, 1 Water container, 1 Tube set, 2 Rectal catheters regular, 1 Accessory set, 1 Navina case. Non Sterile Device. Rx Only.
Catalog Number
6900940
Brand Name
Navina™ Smart System Regular
Version/Model Number
69009
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
b2b90aa9-a257-4656-a6c4-f199e1b62303
Public Version Date
December 27, 2019
Public Version Number
1
DI Record Publish Date
December 19, 2019
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |