Duns Number:354059073
Device Description: Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 T Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, 2 Rectal catheters cone, Non Sterile Device. Rx Only.
Catalog Number
6901840
Brand Name
Navina™ Classic System Cone Refill
Version/Model Number
69018
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
87b3f6f0-2a07-4b4b-b10b-f74bd6c69346
Public Version Date
December 25, 2019
Public Version Number
1
DI Record Publish Date
December 17, 2019
Package DI Number
07392532243813
Quantity per Package
3
Contains DI Package
07392532243806
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 |