SpeediCath Compact 28702

GUDID 05708932653053

SpeediCath Compact with SpeediBag. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Male. Incl. 20 x non-ste

Coloplast A/S

Single-administration urethral drainage catheter

• Primary Device ID: 05708932653053
• NIH Device Record Key: 89519521-3952-47c0-a714-2ccd693d1c3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpeediCath Compact
• Version Model Number: 28702
• Catalog Number: 28702
• 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: true
• 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
• 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

• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Working Length: 30 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 11.8 Inch
• Catheter Gauge: 12 French
• Catheter Working Length: 30 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 11.8 Inch
• Catheter Gauge: 12 French
• Catheter Working Length: 30 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 11.8 Inch
• Catheter Gauge: 12 French
• Catheter Working Length: 30 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 11.8 Inch
• Catheter Gauge: 12 French
• Catheter Working Length: 30 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 11.8 Inch
• Catheter Gauge: 12 French
• Catheter Working Length: 30 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 11.8 Inch
• Catheter Gauge: 12 French
• Catheter Working Length: 30 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 11.8 Inch
• Catheter Gauge: 12 French
• Catheter Working Length: 30 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 11.8 Inch
• Catheter Gauge: 12 French
• Catheter Working Length: 30 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 11.8 Inch
• Catheter Gauge: 12 French
• Catheter Working Length: 30 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 11.8 Inch
• Catheter Gauge: 12 French
• Catheter Working Length: 30 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 11.8 Inch
• Catheter Gauge: 12 French
• Catheter Working Length: 30 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 11.8 Inch
• Catheter Gauge: 12 French
• Catheter Working Length: 30 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 11.8 Inch
• Catheter Gauge: 12 French
• Catheter Working Length: 30 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 11.8 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05701780091183 [Unit of Use]
GS1	05708932653046 [Primary]
GS1	05708932653053 [Package]; Contains: 05708932653046; Package: Shipper box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023254

FDA Product Code

• EZD: Catheter, straight
• 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: 2016-09-01

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