SpeediCath Compact 28110

GUDID 05708932618700

SpeediCath Compact Eve. Sterile urinary catheter for intermittent use. Female ready-to-use coated catheter. Length 3.25 in. FR 10/3.3 mm. Rx only.

Coloplast A/S

Single-administration urethral drainage catheter

• Primary Device ID: 05708932618700
• NIH Device Record Key: 71e48e9b-05a8-417e-bbd1-83dee3d12e4d
• Commercial Distribution Discontinuation: 2017-12-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SpeediCath Compact
• Version Model Number: 28110
• Catalog Number: 28110
• 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: 3.3 Millimeter
• Device Size Text, specify: 0
• Length: 3.25 Inch
• Catheter Gauge: 10 French

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	05708932618694 [Package]; Contains: 05708932618717; Package: Retail box [30 Units]; Discontinued: 2017-12-01; Not in Commercial Distribution
GS1	05708932618700 [Package]; Contains: 05708932618694; Package: Shipper box [10 Units]; Discontinued: 2017-12-01; Not in Commercial Distribution
GS1	05708932618717 [Primary]

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: 2018-04-13
• Device Publish Date: 2016-09-02

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