Home GUDID 05708932640527 SpeediCath Compact
Primary DI 05708932640527
Brand SpeediCath Compact
Company Coloplast A/S
Model 28584
Catalog number 28584
Device description SpeediCath Compact. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Female. Not made with natural rubber lat
Published 2016-09-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name EZD Catheter, straight GBM CATHETER, URETHRAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EZD Catheter, Straight Gastroenterology, Urology 2 GBM Catheter, Urethral Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05708932024594 Package GS1 3 In Commercial Distribution 05708932024785 Package GS1 5 In Commercial Distribution 05708932640510 Package GS1 30 In Commercial Distribution 05708932640527 Package GS1 10 In Commercial Distribution 05708932020572 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05708932024594 05708932024594 5708932024594 05708932024785 05708932024785 5708932024785 05708932640510 05708932640510 5708932640510 05708932640527 05708932640527 5708932640527 05708932020572 05708932020572 5708932020572
GMDN Terms# Term, Definition table Term Definition Single-administration urethral drainage catheter A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 14 French Catheter Working Length 2.7 Inch Catheter Working Length 7 Centimeter Device Size Text, specify 0 Device Size Text, specify 0 Length 3.5 Inch Outer Diameter 4.7 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Do not use if sterile barrier is damaged Special Storage Condition, Specify 0 0 Keep away from sunlight Special Storage Condition, Specify 0 0 Keep away from sunlight. Do not use if package is damaged and consult IFU.
Regulatory Flags# DUNS number 305524696 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# 
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