SpeediCath Soft 27012

GUDID 05708932715652

Intermittent urinary drainage catheter. Ready to use. Nelaton

Coloplast A/S

Single-administration urethral drainage catheter

• Primary Device ID: 05708932715652
• NIH Device Record Key: 4498bde5-639b-4532-bad7-1d1eece3a8f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpeediCath Soft
• Version Model Number: 27012
• Catalog Number: 27012
• 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: true
• 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
• 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

• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 33 Centimeter
• Length: 13 Inch
• Catheter Gauge: 12 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932715638 [Primary]
GS1	05708932715645 [Package]; Contains: 05708932715638; Package: Retail box [30 Units]; In Commercial Distribution
GS1	05708932715652 [Package]; Contains: 05708932715645; Package: shipper box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200142

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: 2020-09-03
• Device Publish Date: 2020-08-26

On-Brand Devices [SpeediCath Soft]

• 05708932715713: Intermittent urinary drainage catheter. Ready to use. Nelaton
• 05708932715676: Intermittent urinary drainage catheter. Ready to use. Nelaton
• 05708932715652: Intermittent urinary drainage catheter. Ready to use. Nelaton
• 05708932715621: Intermittent urinary drainage catheter. Ready to use. Nelaton