AccessGUDID - DEVICE: Bard® CritiCore® Surgipack® with Bardex® LubriCath® Temp Sensing Catheter (00801741019333)

GUDID

Device Identifier (DI) Information

Brand Name: Bard® CritiCore® Surgipack® with Bardex® LubriCath® Temp Sensing Catheter
Version or Model: 900316
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 900316
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741019333
Issuing Agency: GS1
Commercial Distribution End Date: May 17, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Bard® CritiCore® Surgipak®System with Bardex® LubriCath® Temperature Sensing Catheter

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
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)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZC	CATHETER, COUDE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 16 French

Device Record Status

Public Device Record Key: 6dd96ae7-9ba9-46ab-881d-810d631797d1
Public Version Date: May 18, 2022
Public Version Number: 4
DI Record Publish Date: August 06, 2016