Self-Cath Closed System 50297

GUDID 05708932283083

Self-Cath Closed System Kit, Olive Tip. Male. Pre-lubricated Urinary Catheterization System. Contents: Coloplast Self-Cath urethral catheter FR 14, 11

Coloplast A/S

Single-administration urethral drainage catheter

• Primary Device ID: 05708932283083
• NIH Device Record Key: 88635a44-2d27-4d49-ba1e-7d501122cdac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Self-Cath Closed System
• Version Model Number: 50297
• Catalog Number: 50297
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter
• Catheter Gauge: 14 French
• Device Size Text, specify: 0
• Catheter Working Length: 12.2 Inch
• Catheter Working Length: 31 Centimeter

Operating and Storage Conditions

• 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 *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	05708932283083 [Package]; Contains: 05708932289344; Package: Shipper box [50 Units]; In Commercial Distribution
GS1	05708932289344 [Primary]

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: 4
• Public Version Date: 2019-01-24
• Device Publish Date: 2016-09-02

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