Hayden Medical

Basic Information

• Brand Name: Hayden Medical
• Primary DI: 00840319747858
• Version / Model: 285-300
• Catalog Number: 285-300
• Company Name: Hayden Medical, Inc.
• Labeler DUNS: 618214410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-21
• Public Version: 1
• Public Version Date: 2023-03-29
• Public Version Status: New
• Public Device Record Key: 56284a61-43d2-4538-b41b-aab6705f1a2b

Device Description

Walther Female Dilator-Catheters 5-1/4" (13.1cm), (Set of 14) 12Fr.- 38Fr. (4.0mm - 12.7mm)

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FBX	SOUND, URETHRAL, METAL OR PLASTIC	Gastroenterology, Urology	876.5520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42433	Intermittent urethral drainage catheter, non-antimicrobial, reusable	A flexible or rigid tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, the device is typically pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass]; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840319747858	GS1

Customer Contacts

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