Dover 400618

GUDID 20884521008936

Vinyl Urethral Catheter

Cardinal Health, Inc.

Intermittent urethral drainage catheter, reusable

• Primary Device ID: 20884521008936
• NIH Device Record Key: bf5d7999-116f-4d2b-bb48-b024e7f97c6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dover
• Version Model Number: 400618
• Catalog Number: 400618
• Company DUNS: 080935429
• Company Name: Cardinal Health, Inc.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.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
• 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 Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521008939 [Primary]
GS1	20884521008936 [Package]; Contains: 10884521008939; Package: CASE [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810216

FDA Product Code

• KOD: CATHETER, UROLOGICAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-24

On-Brand Devices [Dover]

• 00884521011840: 100% Silicone Foley Catheter,5-10 mL, 2-Way
• 00884521011994: 100% Silicone Foley Catheter,30 mL, 2-Way
• 00884521011987: 100% Silicone Foley Catheter,30 mL, 2-Way
• 00884521011956: 100% Silicone Foley Catheter,30 mL, 2-Way
• 00884521011932: 100% Silicone Foley Catheter,30 mL, 2-Way
• 00884521011925: 100% Silicone Foley Catheter,5-10 mL, 2-Way
• 00884521011895: 100% Silicone Foley Catheter,5-10 mL, 2-Way
• 00884521011871: 100% Silicone Foley Catheter,5-10 mL, 2-Way
• 00884521011819: 100% Silicone Foley Catheter,5-10 mL, 2-Way
• 00884521011789: 100% Silicone Foley Catheter,5-10 mL, 2-Way
• 00884521166625: 100% Silicone Foley Catheter,5-10 mL, 2-Way
• 00884521166618: Paediatric 100% Silicone Foley Catheter,3-5 mL, 2-Way
• 00884521011734: Paediatric 100% Silicone Foley Catheter,3-5 mL, 2-Way
• 20884521723372: Silver Coated 100% Silicone Foley Catheter, 30 ml, 2-Way
• 10884521723368: Silver Coated 100% Silicone Foley Catheter, 30 ml, 2-Way
• 10884521723351: Silver Coated 100% Silicone Foley Catheter, 30 ml, 2-Way
• 10884521723344: Silver Coated 100% Silicone Foley Catheter, 30 ml, 2-Way
• 10884521723337: Silver Coated 100% Silicone Foley Catheter, 30 ml, 2-Way
• 20884521723327: Silver Coated 100% Silicone Foley Catheter, 5 ml, 2-Way
• 20884521723310: Silver Coated 100% Silicone Foley Catheter, 5 ml, 2-Way
• 10884521723306: Silver Coated 100% Silicone Foley Catheter, 5 ml, 2-Way
• 20884521723297: Silver Coated 100% Silicone Foley Catheter, 5 ml, 2-Way
• 10884521723283: Silver Coated 100% Silicone Foley Catheter, 5 ml, 2-Way
• 20884521723273: Silver Coated 100% Silicone Foley Catheter, 5 ml, 2-Way
• 20884521723266: Silver Coated 100% Silicone Foley Catheter, 2-Way
• 20884521723259: Silver Coated 100% Silicone Foley Catheter,2-Way
• 10884521149236: 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor,5 mL
• 10884521149229: 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor,5 mL
• 10884521149212: 100% Silicone Foley Catheter with Temperature Sensor,5 mL
• 20884521149202: 100% Silicone Foley Catheter with Temperature Sensor,5 mL
• 10884521149199: 100% Silicone Foley Catheter with Temperature Sensor,5 mL
• 10884521026599: Silver Coated 100% Silicone Foley Catheter,3-Way
• 20884521026589: Silver Coated 100% Silicone Foley Catheter,3-Way
• 10884521026575: Silver Coated 100% Silicone Foley Catheter,30 mL, 3-Way
• 10884521026568: Silver Coated 100% Silicone Foley Catheter,30 mL, 3-Way
• 10884521019867: 100% Silicone Foley Catheter,Council Tip, 5 mL, 2-Way
• 20884521017174: Silicone Elastomer Coated Latex Foley Catheter,30 mL, 3-Way
• 10884521017146: Silicone Elastomer Coated Latex Foley Catheter,30 mL, 3-Way
• 10884521017139: Silicone Elastomer Coated Latex Foley Catheter,30 mL, 3-Way
• 10884521017122: Silicone Elastomer Coated Latex Foley Catheter,30 mL, 3-Way
• 10884521017115: Silicone Elastomer Coated Latex Foley Catheter,30 mL, 3-Way
• 20884521017105: Silicone Elastomer Coated Latex Foley Catheter,30 mL, 3-Way
• 10884521017092: Silicone Elastomer Coated Latex Foley Catheter,5 mL, 3-Way
• 10884521017085: Silicone Elastomer Coated Latex Foley Catheter,5 mL, 3-Way
• 10884521017078: Silicone Elastomer Coated Latex Foley Catheter,5 mL, 3-Way
• 20884521017068: Silicone Elastomer Coated Latex Foley Catheter,5 mL, 3-Way
• 10884521017054: Silicone Elastomer Coated Latex Foley Catheter,5 mL, 3-Way
• 20884521017044: Silicone Elastomer Coated Latex Foley Catheter,5 mL, 3-Way
• 20884521016146: Hydrogel Coated Latex Foley Catheter,Coude Tip, 5 mL, 2-Way, Red
• 10884521015890: Silicone Elastomer Coated Latex Foley Catheter,Nylon Spiral Reinforced Catheter Wall, 30-50 mL,