Bard® CritiCore® Surgipack® with Bardex® LubriCath® Temp Sensing Catheter

Basic Information

• Brand Name: Bard® CritiCore® Surgipack® with Bardex® LubriCath® Temp Sensing Catheter
• Primary DI: 00801741019333
• Version / Model: 900316
• Catalog Number: 900316
• 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: 2016-08-06
• Public Version: 4
• Public Version Date: 2022-05-18
• Public Version Status: Update
• Public Device Record Key: 6dd96ae7-9ba9-46ab-881d-810d631797d1
• Distribution End Date: 2022-05-17

Device Description

Bard® CritiCore® Surgipak®System with Bardex® LubriCath® Temperature Sensing 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: Yes
• Not Made with NRL: No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EZC	CATHETER, COUDE	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32031	Indwelling urethral catheterization kit, adult	A collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.	No	Active
47458	Urine monitoring system	An assembly of devices intended to automatically and continuously monitor and display a patient's urine output (urine flow/volume). The system typically consists of a battery-powered, portable monitor with controls, digital display, alarms, and memory; an electronic (e.g., optical) urine output sensor; and a disposable urine collection container. The system is typically used in situations where fluid and renal management are critical to patient treatment and care [e.g., during diuresis monitoring in the intensive care unit (ICU)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10801741019330	GS1	CA	10	Not in Commercial Distribution	2021-09-30
Primary	00801741019333	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	16	French