Dover 11086

GUDID 20884521030951

Paediatric Silicone Coated Latex Foley Catheter;3 mL, 2-Way

Cardinal Health, Inc.

Indwelling urethral drainage catheter

• Primary Device ID: 20884521030951
• NIH Device Record Key: dd6deadd-8bf9-4b24-8edb-4d52cdae247e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dover
• Version Model Number: 11086
• Catalog Number: 11086
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• 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
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521030954 [Package]; Package: CASE [100 Units]; In Commercial Distribution
GS1	20884521030951 [Primary]
GS1	30884521030958 [Package]; Package: PACK_OR_INNER_PACK [10 Units]; In Commercial Distribution
GS1	40884521030955 [Package]; Package: PALLET [1000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K860484

FDA Product Code

• GBM: CATHETER, URETHRAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 11
• Public Version Date: 2019-09-16
• Device Publish Date: 2016-09-24

On-Brand Devices [Dover]

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• 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,