Navina™ Classic System Cone Refill 6901840
GUDID 07333387029719
Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, 2 Rectal catheters cone, Non Sterile Device. Rx Only.
Wellspect AB
Manual rectal irrigation system| Primary Device ID | 07333387029719 |
| NIH Device Record Key | 71c7eb99-ea66-454b-ac73-0c36f029fb1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Navina™ Classic System Cone Refill |
| Version Model Number | 69018 |
| Catalog Number | 6901840 |
| Company DUNS | 351118942 |
| Company Name | Wellspect AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07333387029702 [Primary] |
| GS1 | 07333387029719 [Package] Contains: 07333387029702 Package: [3 Units] In Commercial Distribution |
| GS1 | 07392532243806 [Previous] |
FDA Product Code
| FCE | Enema kit |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-03 |
| Device Publish Date | 2023-09-25 |
Devices Manufactured by Wellspect AB
| 07333387052564 - Navina™ Catheter Set Cone | 2025-01-20 Navina Transanal Irrigation. Rectal Catheter set cone. 10 Rectal catheters cone. Single use. Non sterile Device. Rx Only. |
| 07333387052595 - Navina™ Classic System Regular | 2025-01-20 Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, 1 Accessory set, 1 Navina cas |
| 07333387052618 - Navina™ Classic System Refill | 2025-01-20 Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, Non Sterile Device. Rx Only. |
| 07333387052632 - Navina™ Smart System | 2025-01-20 Navina Smart Transanal Irrigation. 1 Navina Smart control unit, 1 Water container, 1 Tube set, 1 Accessory set, 1 Navina case. N |
| 07333387052854 - Navina Mini Refill Set | 2024-11-05 Navina Mini Refill Set. 30 Rectal Cones. Non Sterile Device. |
| 07333387052823 - Navina™ Mini Set | 2024-11-05 Navina Mini Set. 1 Water Container, 30 Rectal Cones. Non Sterile Device. |
| 07333387052847 - Navina Mini Extension Set | 2024-11-05 Navina Mini Extension Set. 1 Water Container, 30 Rectal Cones. 1 extension tube. Non Sterile Device. |
| 07333387052885 - Navina™ Mini Start Set | 2024-11-05 Navina Mini Start Set. 1 Water Container, 5 Rectal Cones. 1 Extension Tube. Non Sterile Device. |
Trademark Results [Navina]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NAVINA 90882312 not registered Live/Pending |
Meriwether Ventures Inc. 2021-08-13 |
 NAVINA 90680900 not registered Live/Pending |
Dentsply Sirona Inc. 2021-04-29 |
 NAVINA 88449953 not registered Live/Pending |
GUANGZHOU NAVINA COSMETIC CO., LTD. 2019-05-29 |
 NAVINA 87979885 5717954 Live/Registered |
DENTSPLY SIRONA Inc. 2017-07-21 |
 NAVINA 87537784 not registered Live/Pending |
DENTSPLY SIRONA Inc. 2017-07-21 |
 NAVINA 86399213 4738575 Live/Registered |
HUME, DREW 2014-09-18 |
 NAVINA 85948696 not registered Dead/Abandoned |
DENTSPLY International Inc. 2013-06-03 |
 NAVINA 79230075 5592647 Live/Registered |
XIE RONG CHU 2017-10-02 |
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