Duette™

GUDID 10852732004002

18FR Duettte™Indwelling Urinary Catheter

POIESIS MEDICAL, LLC

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• Primary Device ID: 10852732004002
• NIH Device Record Key: bf6eafdd-6afc-4198-8e5b-e948093a733d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duette™
• Version Model Number: D-10018
• 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
• Email: sales@poiesismedical.com
• Phone: +1(877)487-5740
• Email: sales@poiesismedical.com
• Phone: +1(877)487-5740
• Email: sales@poiesismedical.com
• Phone: +1(877)487-5740
• Email: sales@poiesismedical.com
• Phone: +1(877)487-5740
• Email: sales@poiesismedical.com
• Phone: +1(877)487-5740
• Email: sales@poiesismedical.com
• Phone: +1(877)487-5740
• Email: sales@poiesismedical.com
• Phone: +1(877)487-5740
• Email: sales@poiesismedical.com
• Phone: +1(877)487-5740
• Email: sales@poiesismedical.com
• Phone: +1(877)487-5740
• Email: sales@poiesismedical.com
• Phone: +1(877)487-5740
• Email: sales@poiesismedical.com
• Phone: +1(877)487-5740
• Email: sales@poiesismedical.com
• Phone: +1(877)487-5740
• Email: sales@poiesismedical.com
• Phone: +1(877)487-5740
• Email: sales@poiesismedical.com
• Phone: +1(877)487-5740
• Email: sales@poiesismedical.com

Device Dimensions

• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 French
• Catheter Gauge: 18 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	00852732004029 [Unit of Use]
GS1	10852732004002 [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

[10852732004002]

Ethylene Oxide

[10852732004002]

Ethylene Oxide

[10852732004002]

Ethylene Oxide

[10852732004002]

Ethylene Oxide

[10852732004002]

Ethylene Oxide

[10852732004002]

Ethylene Oxide

[10852732004002]

Ethylene Oxide

[10852732004002]

Ethylene Oxide

[10852732004002]

Ethylene Oxide

[10852732004002]

Ethylene Oxide

[10852732004002]

Ethylene Oxide

[10852732004002]

Ethylene Oxide

[10852732004002]

Ethylene Oxide

[10852732004002]

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