SpeediCath Compact 28810

GUDID 05708932558907

SpeediCath Compact Plus. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Female. Not made with natural rubbe

Coloplast A/S

Single-administration urethral drainage catheter

• Primary Device ID: 05708932558907
• NIH Device Record Key: 76abfb3c-c00e-4108-95cc-7453b7444019
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpeediCath Compact
• Version Model Number: 28810
• Catalog Number: 28810
• 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

Device Dimensions

• Catheter Gauge: 10 French
• Outer Diameter: 3.3 Millimeter
• Device Size Text, specify: 0

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932020619 [Primary]
GS1	05708932024624 [Package]; Contains: 05708932020619; Package: Sample pack [5 Units]; In Commercial Distribution
GS1	05708932558907 [Package]; Contains: 05708932020619; Package: Retail box [30 Units]; In Commercial Distribution
GS1	05708932558914 [Package]; Package: Shipper box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072808

FDA Product Code

• 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: 2016-09-02

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