SpeediCath Flex Coude 28924

GUDID 05708932017244

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

Coloplast A/S

Single-administration urethral drainage catheter

• Primary Device ID: 05708932017244
• NIH Device Record Key: e8c68d8a-25bf-43f4-91de-573d583f8513
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpeediCath Flex Coude
• Version Model Number: 28924
• Catalog Number: 28924
• 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

Device Dimensions

• Length: 17.32 Inch
• Catheter Gauge: 14 French
• Length: 44 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.7 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932017244 [Package]; Contains: 05708932643597; Package: retail box [30 Units]; In Commercial Distribution
GS1	05708932017312 [Package]; Package: shipper box [3 Units]; In Commercial Distribution
GS1	05708932643597 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161672

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-04

On-Brand Devices [SpeediCath Flex Coude]

• 05708932017244: Ready to use male catheter. Sterile urinary catheter for intermittent catheterization.
• 05708932643689: Ready to use male catheter. Sterile urinary catheter for intermittent catheterization.
• 05708932643672: Ready to use male catheter. Sterile urinary catheter for intermittent catheterization.
• 05708932643665: Ready to use male catheter. Sterile urinary catheter for intermittent catheterization.
• 05708932643658: Ready to use male catheter. Pocket Size. Sterile urinary catheter for intermittent catheterizati
• 05708932643610: Ready to use male catheter. Pocket Size. Sterile urinary catheter for intermittent catheterizati
• 05708932643603: Ready to use male catheter. Pocket Size. Sterile urinary catheter for intermittent catheterizati