SpeediCath Compact 28524

GUDID 05708932543965

SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Ready to use coated catheter. Nelaton. Female. Length: 3.

Coloplast A/S

Single-administration urethral drainage catheter

• Primary Device ID: 05708932543965
• NIH Device Record Key: 81e0434d-aca8-4ccb-bcc3-b157d36080e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpeediCath Compact
• Version Model Number: 28524
• Catalog Number: 28524
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com

Device Dimensions

• Outer Diameter: 4.7 Millimeter
• Length: 3.5 Inch
• Device Size Text, specify: 0
• Catheter Gauge: 14 French
• Total Volume: 750 Milliliter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932024631 [Package]; Contains: 05708932543958; Package: Sample pack [5 Units]; In Commercial Distribution
GS1	05708932543958 [Primary]
GS1	05708932543965 [Package]; Contains: 05708932543958; Package: Retail box [20 Units]; In Commercial Distribution
GS1	05708932543972 [Package]; Package: Shipper box [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121457

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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