Bard® Polyurethane Ureteral Catheters, Open Tip

Basic Information

• Brand Name: Bard® Polyurethane Ureteral Catheters, Open Tip
• Primary DI: 10801741126908
• Version / Model: 134006
• Catalog Number: 134006
• Company Name: C. R. Bard, Inc.
• Labeler DUNS: 016898496
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-07-23
• Public Version: 3
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: 37512b6f-c03e-4851-b27c-2af76a458e69

Device Description

Bard® Polyurethane Ureteral Catheters, Open Tip

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: 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EYB	CATHETER, URETERAL, GASTRO-UROLOGY	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34926	Ureteral catheter	A flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10801741126908	GS1
Unit of Use	00801741126901	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	6	French
Length	69	Centimeter