Navina™ Tube set 6901140
GUDID 07392532198502
Navina Transanal Irrigation. Tube set. 1 Water container tube, 1 Rectal catheter tube. Non Sterile Device. Rx Only.
Dentsply Ih AB
Rectal irrigation system catheter| Primary Device ID | 07392532198502 |
| NIH Device Record Key | 475deac8-7679-4171-b9b9-e66250086da9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Navina™ Tube set |
| Version Model Number | 69011 |
| Catalog Number | 6901140 |
| Company DUNS | 354059073 |
| Company Name | Dentsply Ih 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 | false |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07392532198496 [Primary] |
| GS1 | 07392532198502 [Package] Contains: 07392532198496 Package: Customer pack [3 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170487
FDA Product Code
| KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-04-13 |
| Device Publish Date | 2017-11-10 |
Devices Manufactured by Dentsply Ih AB
| 07333387029023 - Navina™Consumable Set Cone | 2023-09-11 Navina Transanal Irrigation. Consumable set cone. 1 Water container, 15 Rectal catheters cone. Non Sterile device. Rx Only. |
| 07392532208461 - LoFric® Elle™ | 2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH10 / Nelaton 4" 10FR 5-pack |
| 07392532208492 - LoFric® Elle™ | 2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR 5-pack |
| 07392532208522 - LoFric® Elle™ | 2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR 5-pack |
| 07392532274305 - LoFric® Elle™ | 2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH10 / Nelaton 4" 10FR |
| 07392532274336 - LoFric® Elle™ | 2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR |
| 07392532274367 - LoFric® Elle™ | 2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR |
| 07392532247255 - LoFric® Hydro-Kit™ | 2020-12-14 Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 08FR |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.