SpeediCath

Basic Information

• Brand Name: SpeediCath
• Primary DI: 05701780209236
• Version / Model: 28482
• Catalog Number: 28482
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-25
• Public Version: 1
• Public Version Date: 2020-04-02
• Public Version Status: New
• Public Device Record Key: ccf73eae-1c8e-4507-a6ab-dbf9af74f953

Device Description

SpeediCath Standard. Catheter with accessories. Nelaton. Male. 1 Ready to use coated catheter, sterilized using irradiation. FR 10/3.3 mm. 1 Water proof drape, sterilized using ethylene oxide. 2 Non-sterile, non-latex gloves, 2 Non-sterile iodine pads, 1 Non-sterile urine bag, 700 ml. Rx only.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
45605	Single-administration urethral catheterization kit, single-use	A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.	No	Active
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	05701780209076	GS1	Shipper box	100	In Commercial Distribution
Primary	05701780209236	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	3.3	Millimeter
Catheter Gauge	10	French
Device Size Text, specify			Male

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store away from light in a cool and dry place
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if sterile barrier is damaged