DEVICE: Bard® CritiCore® Surgipack® with Bardex® LubriCath® Temp Sensing Catheter (00801741019333)
Device Identifier (DI) Information
Bard® CritiCore® Surgipack® with Bardex® LubriCath® Temp Sensing Catheter
900316
Not in Commercial Distribution
900316
C. R. Bard, Inc.
900316
Not in Commercial Distribution
900316
C. R. Bard, Inc.
Bard® CritiCore® Surgipak®System with Bardex® LubriCath® Temperature Sensing Catheter
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
Yes | |
Yes | |
No | |
Yes | |
Yes | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Catheter Gauge: 16 French |
Device Record Status
6dd96ae7-9ba9-46ab-881d-810d631797d1
May 18, 2022
4
August 06, 2016
May 18, 2022
4
August 06, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10801741019330 | 10 | 00801741019333 | 2021-09-30 | Not in Commercial Distribution | CA |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)526-4455
medical.services@crbard.com
medical.services@crbard.com