Bard® Urethral Catheterization Tray with Plastic Catheter

Basic Information

• Brand Name: Bard® Urethral Catheterization Tray with Plastic Catheter
• Primary DI: 00801741040245
• Version / Model: 800081
• Catalog Number: 800081
• Company Name: C. R. Bard, Inc.
• Labeler DUNS: 016898496
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-28
• Public Version: 3
• Public Version Date: 2022-05-19
• Public Version Status: Update
• Public Device Record Key: 8544981a-7d49-47c8-a278-d3b2587e1128
• Distribution End Date: 2022-05-18

Device Description

Bard® Urethral Catheterization Tray with Plastic Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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
KOD	CATHETER, UROLOGICAL	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	10801741040242	GS1	CA	20	Not in Commercial Distribution	2020-03-01
Primary	00801741040245	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	16	French