DEVICE: Bardex® Silicone Elastomer-Coated Foley Catheter Kit (00801741046582)

Device Identifier (DI) Information

Bardex® Silicone Elastomer-Coated Foley Catheter Kit
710024S
Not in Commercial Distribution
710024S
C. R. Bard, Inc.
00801741046582
GS1
October 13, 2021
1
016898496 *Terms of Use
Bardex® Silicone Elastomer-Coated Foley Catheter Kit
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
Yes
No
Yes
No
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
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: 24 French
CLOSE

Device Record Status

1ab30d3c-e4f7-4291-9f23-c3a057f4935c
November 16, 2021
4
August 16, 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
10801741046589 20 00801741046582 2021-10-13 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