Silicone Foley Catheter Insertion Kit - 14 Fr

Basic Information

• Brand Name: Silicone Foley Catheter Insertion Kit - 14 Fr
• Primary DI: 00860008059505
• Version / Model: 10003
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2022-01-11
• Public Version: 1
• Public Version Date: 2022-01-19
• Public Version Status: New
• Public Device Record Key: 14245faa-81b3-40e1-a7e3-10576d454ecd

Device Description

Silicone Foley Catheter Insertion Kit - 14 Fr

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
61355	Urethral catheterization support kit, urinary drainage	A collection of non-surgically invasive devices intended to assist a healthcare professional to insert a urethral catheter (not included) into the urinary bladder, typically for drainage of urine; some types may also be intended for catheter removal. It typically includes forceps, dressings, gloves, and drapes; it does not include pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860008059505	GS1
Unit of Use	00860008123206	GS1