Duette™
GUDID 10852732004026
16FR Duette™ Indwelling Urinary Catheter
POIESIS MEDICAL, LLC
Indwelling urethral drainage catheter| Primary Device ID | 10852732004026 |
| NIH Device Record Key | 57fe668c-fa56-4574-af63-9bf9e564a036 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Duette™ |
| Version Model Number | D-10016 |
| Company DUNS | 831415109 |
| Company Name | POIESIS MEDICAL, LLC |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(877)487-5740 |
| sales@poiesismedical.com | |
| Phone | +1(877)487-5740 |
| sales@poiesismedical.com | |
| Phone | +1(877)487-5740 |
| sales@poiesismedical.com | |
| Phone | +1(877)487-5740 |
| sales@poiesismedical.com | |
| Phone | +1(877)487-5740 |
| sales@poiesismedical.com | |
| Phone | +1(877)487-5740 |
| sales@poiesismedical.com | |
| Phone | +1(877)487-5740 |
| sales@poiesismedical.com | |
| Phone | +1(877)487-5740 |
| sales@poiesismedical.com | |
| Phone | +1(877)487-5740 |
| sales@poiesismedical.com | |
| Phone | +1(877)487-5740 |
| sales@poiesismedical.com | |
| Phone | +1(877)487-5740 |
| sales@poiesismedical.com | |
| Phone | +1(877)487-5740 |
| sales@poiesismedical.com | |
| Phone | +1(877)487-5740 |
| sales@poiesismedical.com | |
| Phone | +1(877)487-5740 |
| sales@poiesismedical.com | |
| Phone | +1(877)487-5740 |
| sales@poiesismedical.com |
Device Dimensions
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Out of Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Out of Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Out of Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Out of Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Out of Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Out of Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Out of Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Out of Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Out of Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Out of Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Out of Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Out of Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Out of Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Out of Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852732004005 [Unit of Use] |
| GS1 | 10852732004026 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K941488
FDA Product Code
| EZL | CATHETER, RETENTION TYPE, BALLOON |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10852732004026]
Ethylene Oxide
[10852732004026]
Ethylene Oxide
[10852732004026]
Ethylene Oxide
[10852732004026]
Ethylene Oxide
[10852732004026]
Ethylene Oxide
[10852732004026]
Ethylene Oxide
[10852732004026]
Ethylene Oxide
[10852732004026]
Ethylene Oxide
[10852732004026]
Ethylene Oxide
[10852732004026]
Ethylene Oxide
[10852732004026]
Ethylene Oxide
[10852732004026]
Ethylene Oxide
[10852732004026]
Ethylene Oxide
[10852732004026]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 9 |
| Public Version Date | 2020-12-04 |
| Device Publish Date | 2017-01-27 |
On-Brand Devices [Duette™]
| 20852732004047 | 16FR Duette™ Indwelling Urinary Catheter Tray |
| 10852732004132 | 18FR Duette™ Indwelling TempSensing Urinary Catheter Urine Meter Tray |
| 10852732004125 | 16FR Duette™ Indwelling TempSensing Urinary Catheter Urine Meter Tray |
| 10852732004088 | 14FR Duette™ Indwelling Urinary Catheter Urine Meter Tray |
| 10852732004071 | 16FR Duette™ Indwelling Urinary Catheter Urine Meter Tray |
| 10852732004064 | 18FR Duette™ Indwelling Urinary Catheter Urine Meter Tray |
| 10852732004040 | 14FR Duette™ Indwelling Urinary Catheter Tray |
| 10852732004033 | 14FR Duette™ Indwelling Urinary Catheter |
| 10852732004026 | 16FR Duette™ Indwelling Urinary Catheter |
| 10852732004019 | 18FR Duette™ Indwelling Urinary Catheter Tray |
| 10852732004002 | 18FR Duettte™Indwelling Urinary Catheter |
Trademark Results [Duette]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DUETTE 97976607 not registered Live/Pending |
Leebow, Jennifer 2022-10-10 |
 DUETTE 97625432 not registered Live/Pending |
Leebow, Jennifer 2022-10-10 |
 DUETTE 97099728 not registered Live/Pending |
Legendairy Milk, LLC 2021-10-29 |
 DUETTE 88874722 not registered Live/Pending |
Eagles Landing Family Practice, Inc. 2020-04-16 |
 DUETTE 88710040 not registered Live/Pending |
The Great Incorporated 2019-11-28 |
 DUETTE 86926603 5032005 Live/Registered |
Hunter Douglas Inc. 2016-03-02 |
 DUETTE 86791976 not registered Dead/Abandoned |
Todd Meagher 2015-10-19 |
 DUETTE 86042435 not registered Dead/Abandoned |
Todd Meagher 2013-08-20 |
DUETTE 86042435 not registered Dead/Abandoned |
Ashley Hernandez 2013-08-20 |
 DUETTE 85505738 not registered Dead/Abandoned |
Poiesis Medical, LLC 2011-12-29 |
 DUETTE 85335426 not registered Dead/Abandoned |
Christina M. Duncan 2011-06-01 |
 DUETTE 78714893 not registered Dead/Abandoned |
Duncan, Christina 2005-09-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.