SpeediCath Flex Coude Pro 20010

GUDID 05708932125314

Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization.

Coloplast A/S

Single-administration urethral drainage catheter

• Primary Device ID: 05708932125314
• NIH Device Record Key: dc18cb34-544d-4584-9db5-ec013af5c67b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpeediCath Flex Coude Pro
• Version Model Number: 20010
• Catalog Number: 20010
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com

Device Dimensions

• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Working Length: 33 Centimeter
• Catheter Working Length: 13 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932125307 [Primary]
GS1	05708932125314 [Package]; Contains: 05708932125307; Package: Retail box [30 Units]; In Commercial Distribution
GS1	05708932125321 [Package]; Package: Shipper box [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190620

FDA Product Code

• GBM: CATHETER, URETHRAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-22
• Device Publish Date: 2019-07-12

On-Brand Devices [SpeediCath Flex Coude Pro]

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• 05708932674799: Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
• 05708932674751: Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
• 05708932125499: Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
• 05708932125468: Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
• 05708932125437: Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
• 05708932125413: Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
• 05708932125383: Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
• 05708932125352: Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
• 05708932125314: Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
• 05708932765893: 20014
• 05708932765619: 20012
• 05708932765497: 20010
• 05708932766135: 20016