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.
00801741019333
GS1
May 17, 2022
1
016898496 *Terms of Use
Bard® CritiCore® Surgipak®System with Bardex® LubriCath® Temperature Sensing Catheter
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EZC CATHETER, COUDE
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 16 French
CLOSE

Device Record Status

6dd96ae7-9ba9-46ab-881d-810d631797d1
May 18, 2022
4
August 06, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)526-4455
medical.services@crbard.com
CLOSE