SpeediCath Compact 28578

GUDID 05708932640572

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

Coloplast A/S

Single-administration urethral drainage catheter

• Primary Device ID: 05708932640572
• NIH Device Record Key: 00879c92-4b62-4470-860b-4ff7bdf0569a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpeediCath Compact
• Version Model Number: 28578
• Catalog Number: 28578
• 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

• Device Size Text, specify: 0
• Outer Diameter: 2.7 Millimeter
• Catheter Gauge: 8 French
• Length: 3.5 Inch

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	05708932636827 [Primary]
GS1	05708932640572 [Package]; Contains: 05708932636827; Package: Retail box [30 Units]; In Commercial Distribution
GS1	05708932640589 [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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