SpeediCath Flex Coude Pro 20016

GUDID 05708932125413

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

Coloplast A/S

Single-administration urethral drainage catheter

• Primary Device ID: 05708932125413
• NIH Device Record Key: fd6030f8-7ccb-44e9-8cd9-8cbf2d720d50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpeediCath Flex Coude Pro
• Version Model Number: 20016
• Catalog Number: 20016
• 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

• Length: 17.32 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 13 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 13 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 13 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 13 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 13 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 13 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 13 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 13 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 13 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 13 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 13 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 13 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 13 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 13 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 13 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 13 Inch
• Catheter Gauge: 16 French
• Catheter Working Length: 33 Centimeter
• Device Size Text, specify: 0
• 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	05708932125390 [Primary]
GS1	05708932125406 [Package]; Contains: 05708932125390; Package: Retail box [30 Units]; In Commercial Distribution
GS1	05708932125413 [Package]; Contains: 05708932125406; 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]

• 05708932674843: Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
• 05708932674812: Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
• 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