SpeediCath Compact 28580

GUDID 05708932020558

SpeediCath Compact female CH10

Coloplast A/S

Single-administration urethral drainage catheter

• Primary Device ID: 05708932020558
• NIH Device Record Key: 7f1b3a7a-d269-426c-84b6-07fcf4d1ef96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpeediCath Compact
• Version Model Number: 28580
• Catalog Number: 28580
• 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

Device Dimensions

• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Catheter Working Length: 7 Centimeter
• Catheter Working Length: 2.7 Inch
• Device Size Text, specify: 0

Operating and Storage Conditions

• 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	05708932020558 [Primary]
GS1	05708932640558 [Package]; Package: Retail Box [30 Units]; In Commercial Distribution
GS1	05708932640565 [Package]; Contains: 05708932640558; Package: Shipper Box [10 Units]; In Commercial Distribution

FDA Product Code

• EZD: Catheter, straight

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-11-05
• Device Publish Date: 2016-09-27

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• 05708932020558: SpeediCath Compact female CH10