Duns Number:354059073
Device Description: Navina Transanal Irrigation. Rectal Catheter set small. 10 Rectal catheters small. Single Navina Transanal Irrigation. Rectal Catheter set small. 10 Rectal catheters small. Single use. Non sterile Device. Rx Only.
Catalog Number
6894340
Brand Name
Navina™ Catheter set Small
Version/Model Number
68943
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
FCE
Product Code Name
Enema kit
Public Device Record Key
2b7d436e-91ad-49d7-84f6-35c34904b330
Public Version Date
December 25, 2019
Public Version Number
1
DI Record Publish Date
December 17, 2019
Package DI Number
07392532243851
Quantity per Package
3
Contains DI Package
07392532243844
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 |