Dover 8887688243

GUDID 10884521017085

Silicone Elastomer Coated Latex Foley Catheter,5 mL, 3-Way

Cardinal Health, Inc.

Single-administration urethral drainage/irrigation catheter

• Primary Device ID: 10884521017085
• NIH Device Record Key: bd6f1f67-c84b-41db-a988-4ca7ce6a6a9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dover
• Version Model Number: 8887688243
• Catalog Number: 8887688243
• 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

Device Dimensions

• Length: 40 Millimeter
• Length: 40 Millimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521017085 [Package]; Contains: 30884521017089; Package: PACK_OR_INNER_PACK [10 Units]; In Commercial Distribution
GS1	20884521017082 [Package]; Contains: 30884521017089; Package: CASE [60 Units]; In Commercial Distribution
GS1	30884521017089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810630

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: 2019-10-28
• Device Publish Date: 2016-09-24

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