Self-Cath Closed System 50285

GUDID 05708932283021

Self-Cath Closed System. Taper Tip. Male. Pre-lubricated Urinary Catheterization System. FR 14. Rx only.

Coloplast A/S

Single-administration urethral drainage catheter

• Primary Device ID: 05708932283021
• NIH Device Record Key: 48341932-912c-4eea-a348-40ad41d4781f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Self-Cath Closed System
• Version Model Number: 50285
• Catalog Number: 50285
• 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
• 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: 14 French
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Device Size Text, specify: 0

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 package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult IFU.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932279543 [Primary]
GS1	05708932283021 [Package]; Contains: 05708932279543; Package: Shipper box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070939

FDA Product Code

• EZD: CATHETER, STRAIGHT
• FCM: Tray, catheterization, sterile urethral, with or without catheter (kit)

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: 2016-09-02

On-Brand Devices [Self-Cath Closed System]

• 05708932283083: Self-Cath Closed System Kit, Olive Tip. Male. Pre-lubricated Urinary Catheterization System. Con
• 05708932283090: Self-Cath Closed System Kit, Olive Tip. Male. Pre-lubricated Urinary Catheterization System. Con
• 05708932283076: Self-Cath Closed System Kit. Taper Tip. Male. Pre-lubricated Urinary Catheterization System. Con
• 05708932283069: Self-Cath Closed System Kit. Straight Tip. Female. Pre-lubricated Urinary Catheterization System
• 05708932283052: Self-Cath Closed System Kit. Soft Tip. Unisex. Pre-lubricated Urinary Catheterization System. Co
• 05708932283045: Self-Cath Closed System. Olive Tip. Male. Pre-lubricated Urinary Catheterization System. FR 16.
• 05708932283038: Self-Cath Closed System. Olive Tip. Male. Pre-lubricated Urinary Catheterization System. FR 14.
• 05708932283021: Self-Cath Closed System. Taper Tip. Male. Pre-lubricated Urinary Catheterization System. FR 14.
• 05708932283014: Self-Cath Closed System. Straight Tip. Female. Pre-lubricated Urinary Catheterization System. FR
• 05708932282994: Self-Cath Closed System. Soft Tip. Unisex. Pre-lubricated Urinary Catheterization System. FR 14.
• 05708932282987: Self-Cath Closed System. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. FR
• 05708932282970: Self-Cath Closed System. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. FR
• 05708932282963: Self-Cath Closed System. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. FR
• 05708932282956: Self-Cath Closed System. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. FR
• 05708932282949: Self-Cath Closed System. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. FR
• 05708932282932: Self-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System
• 05708932282925: Self-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System
• 05708932282918: Self-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System
• 05708932282901: Self-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System
• 05708932282895: Self-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System