Duette™

GUDID 10852732004064

18FR Duette™ Indwelling Urinary Catheter Urine Meter Tray

POIESIS MEDICAL, LLC

Indwelling urethral catheterization kit, adult

• Primary Device ID: 10852732004064
• NIH Device Record Key: a65016c3-3c99-4078-8d2e-cfbbc71bb914
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duette™
• Version Model Number: K-10018U
• Company DUNS: 831415109
• Company Name: POIESIS MEDICAL, LLC
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

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

• 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep Out of Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852732004067 [Unit of Use]
GS1	10852732004064 [Primary]

FDA Product Code

• OHR: Catheter care tray

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[10852732004064]

Ethylene Oxide

[10852732004064]

Ethylene Oxide

[10852732004064]

Ethylene Oxide

[10852732004064]

Ethylene Oxide

[10852732004064]

Ethylene Oxide

[10852732004064]

Ethylene Oxide

[10852732004064]

Ethylene Oxide

[10852732004064]

Ethylene Oxide

[10852732004064]

Ethylene Oxide

[10852732004064]

Ethylene Oxide

[10852732004064]

Ethylene Oxide

[10852732004064]

Ethylene Oxide

[10852732004064]

Ethylene Oxide

[10852732004064]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• 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