SpeediCath Flex Coude Pro

Basic Information

• Brand Name: SpeediCath Flex Coude Pro
• Primary DI: 05708932765602
• Version / Model: 20012
• Catalog Number: 20012
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-11
• Public Version: 1
• Public Version Date: 2023-11-20
• Public Version Status: New
• Public Device Record Key: 55014bd9-42c5-42d8-a8f6-2592fc01c8db

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GBM	CATHETER, URETHRAL	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45603	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05708932765619	GS1	Retail Box	30	In Commercial Distribution
Primary	05708932765602	GS1
Package	05708932765626	GS1	Shipper Box	2	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K190620	000

Device Sizes

Type	Value	Unit	Text
Catheter Working Length	33	Centimeter
Catheter Working Length	13	Inch
Catheter Gauge	12	French
Device Size Text, specify			Tip Type Flex Coudé

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight. Do not use if package is damaged and consult IFU.